FDA New Approvals
The FDA has approved the first subcutaneous self-injection treatment option for systemic lupus erythematosus (SLE), Benlysta (belimumab). Benlysta is indicated for treatment of adults with active, autoantibody-positive SLE who are receiving standard therapy. Belimumab is a B-lymphocyte stimulator protein inhibitor that is thought to decrease the amount of abnormal B cells. It is hypothesized that an abnormal level of B cells is a mechanism of action in lupus. An intravenous formulation of belimumab was approved previously by the FDA in 2011.
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Embrace Neonatal MRI System
The FDA cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units. The Embrace Neonatal MRI System is designed specifically for imaging of the neonatal head. The Embrace Neonatal MRI System may be used on neonates with a head circumference up to 38 centimeters and weight between 1 and 4.5 kilograms. The system has a temperature-controlled incubator placed directly into the MRI system, minimizing movement of the baby. If urgent access to the baby is necessary during the imaging process, the baby can typically be removed from the system in less than 30 seconds.
Learn more about the Embrace Neonatal MRI System
The FDA has approved a supplemental New Drug Application for Fycompa (perampanel) CIII as monotherapy to treat partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. Fycompa is the first antiepileptic drug approved by the FDA following the pathway outlined in the agency's September 13, 2016 General Advice Letter to antiepileptic drug New Drug Application holders.
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The FDA approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation as detected by an FDA-approved test. The approved recommended dose is 100mg once daily with or without food until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response.
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The FDA approved Mavyret (glecaprevir/pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both. Mavyret is the first treatment of eight weeks’ duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Standard treatment length was previously 12 weeks or more. Mavyret is not recommended in patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin.
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The FDA approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab. Patients should be given loperamide for the first 56 days of treatment with Nerlynx and as needed thereafter to help manage diarrhea.
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FDA granted accelerated approval to Opdivo (nivolumab) for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
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The FDA approved Rituxan Hycela, a combination of rituximab (a CD20-directed cytolytic antibody) and hyaluronidase (an endoglycosidase), for subcutaneous injection using pharmacokinetic comparability assessment. Rituxan Hycela is approved for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. The approval provides patients a subcutaneous route of rituximab administration that shortens the administration time to 5 to 7 minutes as compared to intravenous infusion that can take several hours. This new product also provides for flat dosing.
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The FDA approved Vosevi (voxilaprevir/sofosbuvir/velpatasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs, sofosbuvir and velpatasvir, and a new drug, voxilaprevir. Vosevi is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein called NS5A.
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The FDA approved Vyxeos (daunorubicin and
cytarabine) liposome for injection for the treatment of adult patients with
newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with
myelodysplasia-related changes (AML-MRC). The approved recommended dosage of Vyxeos
is 44mg/100mg per m2
(daunorubicin/cytarabine) administered as a 90-minute intravenous infusion or
more on days 1, 3, and 5 for the first induction cycle and on days 1 and 3 for
subsequent induction cycle(s) if needed. Prior to initiation induction,
assess cardiac function and obtain liver and renal function studies. A dose of
29mg/65mg per m2
on days 1 and 3 via intravenous infusion
over 90 minutes or more is recommended
for consolidation cycle(s).
Learn more about Vyxeos
FDA First-Time Generic Approvals
Isoproterenol Hydrochloride Injection USP, 0.2mg/mL and 1mg/5mL (0.2mg/mL) Single-Dose Vials
This new generic for Isuprel is indicated for mild or transient episodes of heart block that do not require electric shock or pacemaker therapy; serious episodes of heart block and Adams-Stokes attacks, congestive heart failure, cardiogenic shock, and other serious issues.
Learn more about isoproterenol hydrochloride injection
Mesalamine Delayed-Release Tablets USP, 800mg
This new generic for Asacol HD is indicated for the treatment of moderately active ulcerative colitis in adults.
Learn more about mesalamine delayed-released tablets
Minoxidil Topical Aerosol 5% For Women
This new generic for women’s Rogaine is indicated to regrow hair on the top of the scalp.
Learn more about minoxidil topical aerosol for women
Prasugrel Tablets 5mg, 10mg
This new generic for Effient is a P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in certain patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention.
Learn more about prasugrel tablets
Sevelamer Carbonate Tablets 800mg
This new generic for Renvela is indicated for the control of serum phosphorus in adults with chronic kidney disease on dialysis.
Learn more about sevelamer carbonate tablets
Testosterone Topical Gel 1.62% (20.25mg/1.25g packet), 1.62% (40.5mg/2.6g packet)
This new generic for Androgel topical gel is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
Learn more about testosterone topical gel
Ultacan (Articaine Hydrochloride and Epinephrine) Injection, USP 4% / 1:200,000
This new generic for Septocaine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures.
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FDA Labeling Updates
The FDA approved a safety labeling change for Aciphex Sprinkles (rabeprazole sodium) that contains a new subsection that includes cutaneous lupus erythematosus and systemic lupus erythematosus being reported in patients taking PPIs, including rabeprazole.
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The FDA approved safety labeling changes for Altoprev (lovastatin) to include interstitial lung disease as a possible respiratory adverse reaction based on postmarketing experience.
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The FDA approved safety labeling changes for Crestor (rosuvastatin calcium) to include interstitial lung disease as a possible respiratory adverse reaction based on postmarketing experience.
Learn more about Crestor labeling changes
Cubicin and Cubicin RF
The FDA revised the
label of two forms of the antibiotic Cubicin and Cubicin RF (daptomycin)
to warn about a medication error that clinicians could commit. The labels
now state that each drug is reconstituted from powder differently, a sodium
chloride solution for Cubicin and either sterile or bacteriostatic water for
injection for Cubicin RF. Differences also extend to how the drugs are stored.
Learn more about Cubicin and Cubicin RF labeling changes
The FDA approved a safety label change for Invokamet XR (canagliflozin/metformin hydrochloride) to include a boxed warning for risk of lower limb amputation. An approximate 2-fold increased risk of lower limb amputations associated with canagliflozin was observed in CANVAS and CANVAS-R, two large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD.
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The FDA approved a safety label change for Invokana (canagliflozin) to include a boxed warning for risk of lower limb amputation. An approximate 2-fold increased risk of lower limb amputations associated with canagliflozin was observed in CANVAS and CANVAS-R, two large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD.
Learn more about Invokana labeling changes
The Keppra (levetiracetam) label section on adverse reactions after FDA approval was updated to include the risk for acute kidney injury. The change also applies to the extended-release version of the drug.
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The FDA approved safety labeling changes for Liptruzet (atorvastatin calcium ezetimibe) to include interstitial lung disease as a possible respiratory adverse reaction based on postmarketing experience.
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FDA New Indications
The FDA approved Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD. The FDA previously approved ibrutinib for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma with 17p deletion, Waldenström’s macroglobulinemia, marginal zone lymphoma, and mantle cell lymphoma. The recommended dose of ibrutinib for cGVHD is 420mg taken orally once daily (three 140mg capsules once daily).
Learn more about Imbruvica
Apace Packaging LLC Cyclobenzaprine HCl Tablets and Amantadine HCl Capsules
Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been recalled due to a potential mislabeling. A small number of cartons containing Cyclobenzaprine HCl Tablets 5 mg UD Blister Cards may potentially be mislabeled as Amantadine HCl Capsules, USP 100 mg. The unit dose blisters inside the carton are correctly labeled as Cyclobenzaprine HCl Tablet, USP 5 mg. Apace Packaging LLC has notified its distributors and customers by email and is arranging for return of all recalled product.
Learn more about the Apace Packaging LLC cyclobenzaprine HCl and amantadine HCl recall
Bestherbs Coffee LLC New Kopi Jantan Tradisional Natural Herbs Coffee
Bestherbs Coffee LLC is voluntarily recalling all lots of New Kopi Jantan Tradisional Natural Herbs Coffee, 13 grams to the consumer level. FDA laboratory analysis confirmed the presence of desmethyl carbodenafil. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction. New Kopi Jantan Tradisional Natural Herbs Coffee is used as a male enhancement and is packaged in 13g red packs, UPC 557205060083 in a box and each box contains 25 packets. Bestherbs Coffee LLC distributed this product from July 2014 through June 2016. New Kopi Jantan Tradisional Natural Herbs Coffee was distributed nationwide to consumers via individuals or the internet. Bestherbs Coffee LLC is notifying its customers by phone. Consumers that have New Kopi Jantan Tradisional Natural Herbs Coffee should stop using/discard and contact their doctor.
Learn more about the Bestherbs Coffee LLC New Kopi Jantan Tradisional Natural Herbs Coffee recall
Cantrell Drug Company Sterile Drug Products
Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. The recalled products were distributed to healthcare facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and Vermont. The affected products include all lots distributed February 16, 2017 to July 19, 2017, remaining within expiry, and they would be packaged in a syringe or IV bag. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life threatening. Cantrell Drug Company is notifying its customers by email and phone, and is arranging for the return of all recalled products. Anyone with product subject to the recall should stop using it and contact the company.
Learn more about the Cantrell Drug Company sterile drug products recall
Datascope Corp./MAQUET Intra-Aortic Balloon Pumps
Datascope Corp./MAQUET is recalling its CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps manufactured before June 30, 2013, due to the risk of a valve failure which prevents the balloon from inflating and deflating properly. If a patient requires circulatory support with an IABP and the device does not work, or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death. On June 30, 2013, a design change was implemented to prevent this problem, but not all devices manufactured prior to June 13, 2013 have been serviced and upgraded. Datascope Corp./MAQUET sent affected customers an "Urgent Product Recall Medical Device Field Correction" notice informing them of the device's risks and listing actions that should be taken to minimize the risk of patient harm until affected IABP units can be serviced.
Learn more about the Datascope Corp./MAQUET intra-aortic balloon pump recall
EZ Weight Loss TX La Bri’s Body Health Atomic and Xplode Capsules
EZ Weight Loss TX is voluntarily recalling all lots of La Bri's Body Health Atomic and Xplode capsules to the consumer level. Atomic is packaged in 60-count bottles and Xplode is packaged in 30-count bottles. All lots and codes of Atomic and Xplode are included in this recall and were sold nationwide through internet sales starting in 2015. FDA analysis has found the products to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons. EZ Weight Loss TX is asking its customers to contact them via email or phone to arrange for a return or refund of any unused portion or replacement on these recalled products. Consumers that have these products should stop using immediately.
Learn more about the EZ Weight Loss TX La Bri’s Body Health Atomic and Xplode capsules recall
Fujifilm ED-530XT Duodenoscopes
Fujifilm issued an Urgent Medical Device Correction and Removal notification informing customers of its voluntary recall of all ED-530XT duodenoscopes. This action includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new Operation Manuals. The FDA cleared the updated design and labeling for the ED-530XT on July 21, 2017.
Learn more about the Fujifilm ED-530XT duodenoscopes recall
GlaxoSmithKline Menveo Intramuscular Injection
is recalling Menveo [meningococcal
(groups A, C, Y and W-135) oligosaccharide
conjugate vaccine] solution for intramuscular injection 5 doses (10 vials) per package lot M16095. The recall
is a precautionary measure since the associated batch was subject to a
mechanical intervention executed during the aseptic filling operations, which
is not supported by validation data. Recalled product was shipped between January 4, 2017
and January 16, 2017. GSK is asking consignees of (Menveo lot M16095 only)
to stop distributing and immediately quarantine and return all units.
Learn more about the GSK Menveo intramuscular injection recall
ICU Medical, Inc. 0.9% Sodium Chloride Injection
ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container. Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local irritation and inflammation in organs or tissues, or other serious adverse health consequences. The affected product lot was manufactured in the U.S. by Hospira, a Pfizer company, on February 1, 2016 and was distributed nationwide to Hospira customers between April 14, 2016 and February 2, 2017. The affected lot is: NDC 0409-7983-09, Lot # 61-841-FW Expires January 01, 2018 - 1000mL Single Dose Flexible Container. ICU Medical is notifying its distributors and customers of this recall by letter and is arranging for the return of all recalled products. Hospitals/distributors that have product that is being recalled should stop use/further distribution and return to place of purchase.
Learn more about the ICU Medical, Inc. 0.9% sodium chloride injection recall
International Laboratories, LLC Pravastatin Sodium Tablets
International Laboratories, LLC is voluntarily recalling one lot of pravastatin sodium tablets USP 40mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as pravastatin sodium tablets USP 40 mg but contained bupropion hydrochloride XL 300mg tablets. The affected product is NDC# 54458-925-16; Lot# 115698A. No complaints or reports of medical illnesses or harmful effects have been received to date.
Learn more about the International Laboratories, LLC pravastatin sodium tablets recall
Man of Steel Man of Steel 1 and Man of Steel 2
Man of Steel is voluntarily recalling 175 lots of Man of Steel 1 and Man of Steel 2, 4000mg at the retail level. The products have been found to contain undeclared sildenafil. The product has/potentially could result in death. The groups affected are men with diabetes, high blood pressure, high cholesterol, or heart disease. The product is marketed as a male enhancement supplement and is packaged in individual blister packaging. The affected product Man of Steel lots include the following expiration date: 10-17-18. Man of Steel was distributed throughout local convenience stores in Sacramento, California. Man of Steel is notifying its distributors and customers by print media and is arranging for return/replacement of all recalled products. Consumers/distributors/retailers that have Man of Steel which is being recalled should stop using/return to place of purchase/discard/contact their doctor.
Learn more about the Man of Steel 1 and Man of Steel 2 recall
Penumbra Inc. 3D Revascularization Device
Penumbra Inc. is performing a Class I recall of the Penumbra 3D Revascularization Device because there is a risk of the delivery wire breaking or separating during use. Fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces can make the stroke worse. This can also cause other serious adverse health consequences such as continued blockage of blood vessels, completion of the stroke and death.
Learn more about the Penumbra Inc. 3D Revascularization Device recall
PharmaTech LLC and Rugby Laboratories, Major Pharmaceuticals and Leader Brands Products
precautionary measure, the distribution firms Leader Brand, Major
Pharmaceuticals, and Rugby Laboratories are jointly issuing a nationwide
voluntary recall of all lots within expiry of all liquid products manufactured
by PharmaTech LLC at its FDA registered facility in Davie, Florida, due to
possible product contamination with the bacteria Burkholderia
cepacia (B. cepacia) and the
risk for severe patient infection. The drug and dietary supplement products made by PharmaTech include
liquid docusate sodium drugs (stool softeners), as well as various dietary supplements including liquid vitamin D
drops and liquid multivitamins marketed for infants and children. The distribution
firms are notifying their distributors and customers by recall letter and are
arranging for return of all recalled products.
Learn more about PharmaTech LLC and Rugby Laboratories, Major Pharmaceuticals and Leader Brands recall
The AMPT Life, LLC AMPT Coffee
The AMPT Life, LLC is voluntarily recalling all lots of AMPT Coffee to the consumer level. FDA laboratory analysis confirmed the presence of sildenafil and tadalafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction. AMPT Coffee is used as a libido booster and is packaged in a red box and red packets with black writing, UPC 6942630912. The AMPT Life, LLC distributed this product from April 2016 through March 2017. AMPT Coffee is consumed as an instant coffee. AMPT Coffee was distributed nationwide to consumers via the internet. The AMPT Life, LLC is notifying its customers by email. Consumers that have AMPT Coffee, which is being recalled, should stop using and discard any remaining coffee.
Learn more about The AMPT Life, LLC AMPT coffee recall
Ultra Shop Supplement Super Panther 7K Capsules
Ultra Shop Supplement is voluntarily recalling Super Panther 7K capsules, (1 count blister card Lot#: RO846356 and 6 count bottle Lot RO246852 within expiry), distributed by SX Power Co., to the consumer level. FDA analysis found samples of Super Panther 7K to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterase 5-inhibitors, used to treat erectile dysfunction.
Learn more about the Ultra Shop Supplement Super Panther 7K capsules recall
Balguti Kesaria Ayurvedic Medicine
The FDA is warning parents and caregivers not to use Balguti Kesaria (or Kesaria Balguti) Ayurvedic Medicine due to the risk of lead poisoning. This product is sold online and manufactured by multiple companies, including Kesari Ayurvedic Pharmacy in India. Individuals have also mailed or brought the product into the U.S. Balguti Kesaria Ayurvedic Medicine is used with infants and children for a variety of conditions including rickets, cough and cold, worms and dentition (teething). The FDA has not reviewed this product for safety or effectiveness. Exposure to lead can cause serious damage to the central nervous system, the kidneys and the immune system. In children, chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ, behavioral difficulties and other problems. Anyone who is using this product or giving it to a child should stop immediately and consult a healthcare professional.
Learn more about Balguti Kesaria Ayurvedic Medicine
Guardian Pharmacy Services Compounded Triamcinolone and Moxifloxacin for Intravitreal Injection
The FDA received adverse event reports on April 5 and June 1, 2017, and conducted follow-up, concerning at least 43 patients who were administered intravitreal injections of a drug containing triamcinolone and moxifloxacin compounded by Guardian Pharmacy Services in Dallas, Texas. The patients were administered Guardian’s product at the end of a cataract surgery procedure at the PRG Dallas Ambulatory Surgery Center in Dallas, Texas, by physicians affiliated with the Key Whitman Eye Center, and at the Park Central Surgical Center in Dallas, Texas, by physicians affiliated with Tylock-George Eye Care. According to information received from Park Central, Guardian’s product was injected into the vitreous of the eye at the end of the cataract surgery procedure. Over the course of several months, patients developed various symptoms, including vision impairment (blurred or decreased vision), poor night vision, loss of color perception, photophobia (light sensitivity), glare, halos, flashing lights, ocular discomfort, pain, loss of balance, headaches, and/or nausea.
Learn more about Guardian Pharmacy Services compounded triamcinolone and moxifloxacin intravitreal injection
ImprimisRx Compounded Curcumin Emulsion Product for Injection
Two patients administered infusions of curcumin (a component of the spice turmeric) compounded with polyethylene glycol (PEG) 40 castor oil reportedly experienced immediate hypersensitivity reactions, including a 30-year-old female patient who experienced cardiac arrest after IV administration of the curcumin emulsion product and subsequently died. The PEG 40 castor oil was a component of a curcumin emulsion product compounded by a pharmacy, ImprimisRx. Hypersensitivity reactions to intravenous products containing PEG castor oil have been reported and are the subject of warnings for a number of FDA-approved drugs.
Learn more about ImprimisRx compounded curcumin injection
Vital Rx Inc., dba Atlantic Pharmacy and Compounding Sterile Drug Products
The FDA is alerting healthcare professionals and patients not to use drug products intended to be sterile that are produced and distributed nationwide by Vital Rx Inc., dba Atlantic Pharmacy and Compounding, Pompano Beach, Florida, due to lack of sterility assurance. Healthcare professionals and patients should immediately check their medical supplies, quarantine any drug products labeled as sterile from Atlantic Pharmacy and not administer them to patients. Healthcare professionals should make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards.
Learn more about Vital Rx Inc., dba Atlantic Pharmacy and Compounding sterile drug products