May 25, 2022DrugsFDA
Apotex Corp. recalls Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Ma
Hazard: Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
May 25, 2022DrugsFDA
American Health Packaging recalls Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10
Hazard: Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
May 25, 2022DrugsFDA
Bestco LLC recalls Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30
Hazard: Subpotent drug: Low OOS for menthol content at the three month room temperature.
May 25, 2022DrugsFDA
Monarch PCM, LLC recalls Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals,
Hazard: Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
May 25, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-1
Hazard: Failed Stability Specification
May 25, 2022DrugsFDA
Pfizer Inc. recalls Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pf
Hazard: CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
May 25, 2022DrugsFDA
Pfizer Inc. recalls Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pf
Hazard: CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
May 25, 2022DrugsFDA
Pfizer Inc. recalls Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfi
Hazard: CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
May 25, 2022DrugsFDA
Plastikon Healthcare LLC recalls Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 tr
Hazard: CGMP Deviations: Failure to properly investigate failed microbial testing.
May 25, 2022DrugsFDA
Plastikon Healthcare LLC recalls MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton
Hazard: CGMP Deviations: Failure to properly investigate failed microbial testing.
May 25, 2022DrugsFDA
Plastikon Healthcare LLC recalls Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutiona
Hazard: CGMP Deviations: Failure to properly investigate failed microbial testing.
May 25, 2022DrugsFDA
Plastikon Healthcare LLC recalls Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 tr
Hazard: Microbial Contamination of Non-Sterile Products
May 25, 2022DrugsFDA
Plastikon Healthcare LLC recalls MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton
Hazard: Microbial Contamination of Non-Sterile Products
May 18, 2022DrugsFDA
Fagron, Inc recalls Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 740
Hazard: Subpotent Drug
May 18, 2022DrugsFDA
Fagron, Inc recalls Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 74
Hazard: Subpotent Drug
May 18, 2022DrugsFDA
Fagron, Inc recalls Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Kn
Hazard: Subpotent Drug
May 18, 2022DrugsFDA
Fagron, Inc recalls Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot K
Hazard: Subpotent Drug
May 18, 2022DrugsFDA
Fagron, Inc recalls Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot K
Hazard: Subpotent Drug
May 18, 2022DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Caps
Hazard: Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
May 18, 2022DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Caps
Hazard: Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
May 18, 2022DrugsFDA
Lula Holdings L.L.C. recalls Kill 'Dat Sanitizing Products Hand Sanitizer, 1 gallon (128 fl. oz.) 80% Alcohol, OTC, Manufactured by: Lula Holdings L
Hazard: CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
May 18, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmace
Hazard: Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
May 18, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-c
Hazard: Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
May 18, 2022DrugsFDA
Fagron, Inc recalls SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 515
Hazard: Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
May 18, 2022DrugsFDA
Amgen, Inc. recalls MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Ma
Hazard: Defective container: loose crimp defect, potential loss of container integrity.
May 18, 2022DrugsFDA
Viatris Inc recalls Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Di
Hazard: Failed Dissolution Specifications: low out of specification results for dissolution.
May 11, 2022DrugsFDA
Best Brands Consumer Products, Inc. recalls The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best
Hazard: Chemical Contamination; FDA analysis found product to contain benzene
May 11, 2022DrugsFDA
Best Brands Consumer Products, Inc. recalls Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands Consumer Products, Inc., c/o Best Bra
Hazard: Chemical Contamination; FDA analysis found product to contain methanol
May 11, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister
Hazard: Failed Dissolution Specifications
May 11, 2022DrugsFDA
Torrent Pharma Inc recalls Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharma
Hazard: CGMP deviations: tablets cracking