May 4, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc.,
Hazard: cGMP deviations
May 4, 2022DrugsFDA
American Health Packaging recalls Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Ma
Hazard: Subpotent Drug: Out of specification for assay.
May 4, 2022DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
May 4, 2022DrugsFDA
RemedyRepack Inc. recalls Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
May 4, 2022DrugsFDA
AptaPharma Inc. recalls Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd.
Hazard: Incorrect/Undeclared Excipient: Product contains alcohol
May 4, 2022DrugsFDA
Torco Race Fuels recalls TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, Hand Sanitizer Non-Sterile Solution, FDA App
Hazard: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
May 4, 2022DrugsFDA
Unilever United States Inc. recalls Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydrate (19.1%), packaged in 6 oz. cans, Uni
Hazard: CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
May 4, 2022DrugsFDA
Unilever United States Inc. recalls Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chlorohydrate (19.1%), packaged in a) 4 oz. cans
Hazard: Chemical contamination: presence of benzene
April 27, 2022DrugsFDA
Pink Toyz recalls Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chat
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
April 27, 2022DrugsFDA
VIRGIN SCENT INC recalls artnaturals Hand Sanitizer
Hazard: CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
April 27, 2022DrugsFDA
VIRGIN SCENT INC recalls artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnatur
Hazard: CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
April 27, 2022DrugsFDA
VIRGIN SCENT INC recalls artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnatur
Hazard: Chemical Contamination: presence of benzene, acetaldehyde, and acetal.
April 27, 2022DrugsFDA
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
April 27, 2022DrugsFDA
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
April 27, 2022DrugsFDA
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
April 27, 2022DrugsFDA
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
April 27, 2022DrugsFDA
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenvill
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
April 27, 2022DrugsFDA
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
April 27, 2022DrugsFDA
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson,
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
April 27, 2022DrugsFDA
Mylan Pharmaceuticals Inc recalls Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morga
Hazard: Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
April 27, 2022DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Pre
Hazard: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
April 20, 2022DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pharmaceuticals, Inc., The Physican'
Hazard: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
April 20, 2022DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delayed-Release Capsules, 15mg, Generic for Prev
Hazard: Out of specification results observed in dissolution during long term stability testing.
April 20, 2022DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED
Hazard: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
April 20, 2022DrugsFDA
Aurobindo Pharma USA Inc. recalls Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for A
Hazard: Subpotent Drug: Out of Specification results for Assay
April 20, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmac
Hazard: Presence of Particulate Matter: Product was found to contain silica and iron oxide
April 13, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manu
Hazard: Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
April 13, 2022DrugsFDA
Adamis Pharmaceuticals Corporation recalls SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only,
Hazard: Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
April 13, 2022DrugsFDA
Adamis Pharmaceuticals Corporation recalls SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, M
Hazard: Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
April 13, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 0
Hazard: FAILED CONTENT UNIFORMITY SPECIFICATIONS