September 29, 2021DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc.,
Hazard: CGMP Deviations
September 29, 2021DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx on
Hazard: Lack of Assurance of Sterility
September 29, 2021DrugsFDA
Phe Inc recalls X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2
Hazard: Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
September 29, 2021DrugsFDA
Monarch PCM, LLC recalls Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Phar
Hazard: Subpotency: one product for active ingredient assay and another one for preservative assay
September 29, 2021DrugsFDA
Monarch PCM, LLC recalls Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl
Hazard: Subpotency: one product for active ingredient assay and another one for preservative assay
September 29, 2021DrugsFDA
Morton Grove Pharmaceuticals, Inc. recalls Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsip
Hazard: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
September 29, 2021DrugsFDA
Morton Grove Pharmaceuticals, Inc. recalls Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint
Hazard: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
September 29, 2021DrugsFDA
Morton Grove Pharmaceuticals, Inc. recalls Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured F
Hazard: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
September 29, 2021DrugsFDA
American Health Packaging recalls Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Heal
Hazard: Failed Impurities/Degradation Specifications
September 29, 2021DrugsFDA
Aurobindo Pharma USA Inc. recalls Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princ
Hazard: Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
September 29, 2021DrugsFDA
Pfizer Inc. recalls Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfiz
Hazard: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
September 29, 2021DrugsFDA
Pfizer Inc. recalls Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 100
Hazard: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
September 29, 2021DrugsFDA
Pfizer Inc. recalls Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10
Hazard: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
September 29, 2021DrugsFDA
Pfizer Inc. recalls Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, N
Hazard: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
September 29, 2021DrugsFDA
The Harvard Drug Group recalls Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals
Hazard: Failed Dissolution Specifications
September 29, 2021DrugsFDA
The Harvard Drug Group recalls Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177
Hazard: Failed Dissolution Specifications
September 22, 2021DrugsFDA
ICU Medical Inc recalls AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Fore
Hazard: Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
September 22, 2021DrugsFDA
Prescription Labs Inc dba Greenpark recalls Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
Hazard: Lack of Assurance of Sterility
September 22, 2021DrugsFDA
Promise Pharmacy, LLC recalls MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx o
Hazard: Lack of processing controls
September 22, 2021DrugsFDA
Akorn, Inc. recalls Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottl
Hazard: Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
September 22, 2021DrugsFDA
Meitheal Pharmaceuticals Inc recalls Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago,
Hazard: Failed Impurities/Degradation Specifications
September 22, 2021DrugsFDA
Teligent Pharma, Inc. recalls Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey
Hazard: Superpotent Drug
September 22, 2021DrugsFDA
Vi-Jon, Inc. recalls Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Dist. By The Kroger Co., Cincinnati, Ohio 452
Hazard: Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces
September 22, 2021DrugsFDA
Viatris recalls Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV
Hazard: Failed Impurities/Degradation Specifications; out of specification for Related Compound
September 22, 2021DrugsFDA
Ebay Seller - John Nguyen recalls Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 88
Hazard: Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
September 22, 2021DrugsFDA
Grupo Asimex de Mexico SA de CV recalls Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 f
Hazard: CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
September 22, 2021DrugsFDA
Grupo Asimex de Mexico SA de CV recalls Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 f
Hazard: Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
September 22, 2021DrugsFDA
Rhodes Pharmaceuticals, L.P. recalls Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coven
Hazard: Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
September 15, 2021DrugsFDA
NATIVE PROMOTIONS, INC recalls QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics
Hazard: Subpotent
September 15, 2021DrugsFDA
Charles Paint Research Inc recalls HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6
Hazard: CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.