Drug recalls
627 recallsCura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes
Dabur India Limited
CGMP Deviations;
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine
Keystone Industries
Defective container:may contain bottles with incomplete seals
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR
PAI Holdings LLC
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL)
Keystone Industries
Defective container:may contain bottles with incomplete seals
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle
Inventia Healthcare Limited
Failed Dissolution Specifications
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor
Keystone Industries
Defective container:may contain bottles with incomplete seals
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets
Ajanta Pharma USA Inc
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as A…
Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor
Keystone Industries
Defective container:may contain bottles with incomplete seals
Budesonide Inhalation Suspension, 1mg/2mL
SUN PHARMACEUTICAL INDUSTRIES INC
Presence of Foreign Substance:This recall has been initiated in response to a product quality com…
Zep, Alcohol Sanitizer Spray, Ethanol 70%
Zep Inc
Microbial contamination of sterile products
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS
Haleon US Holdings LLC
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machin…
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only
Amneal Pharmaceuticals, LLC
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetac…
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse
BEEKEEPER'S NATURALS USA INC.
Microbial Contamination of Non-Sterile Products
Duloxetine Delayed-Release Capsules, USP, 60mg
Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only
Fresenius Kabi USA, LLC
Failed Impurities/Degradations Specifications
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL)
SUN PHARMACEUTICAL INDUSTRIES INC
Presence of Particulate matter: Particulate matter identified as glass.
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles
Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG
Golden State Medical Supply Inc.
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was o…
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg
Ascend Laboratories, LLC
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9…
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles
Lannett Company Inc.
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolutio…
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only
Ascend Laboratories, LLC
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx
Asclemed USA Inc.
CGMP Deviations;
TopCare health, EXTRA STRENGTH, Antacid Tablets
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only
SUN PHARMACEUTICAL INDUSTRIES INC
Labeling: Not Elsewhere Classified.