March 11, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuti
Hazard: Failed Impurities/Degradation Specification; high out of specification results observed
March 11, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL,
Hazard: Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
March 4, 2020DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single -
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
March 4, 2020DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries L
Hazard: Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
March 4, 2020DrugsFDA
Akorn, Inc. recalls CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Wo
Hazard: Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
March 4, 2020DrugsFDA
Akorn, Inc. recalls Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd.,
Hazard: Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
March 4, 2020DrugsFDA
Akorn, Inc. recalls Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 174
Hazard: Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
March 4, 2020DrugsFDA
Golden State Medical Supply Inc. recalls TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 6042
Hazard: Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
February 26, 2020DrugsFDA
AuroMedics Pharma LLC recalls Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intrav
Hazard: Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
February 26, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles
Hazard: Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
February 26, 2020DrugsFDA
NCS Healthcare of Kentucky Inc recalls Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangar
Hazard: Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
February 26, 2020DrugsFDA
American Health Packaging recalls Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by:
Hazard: GMP Deviations: Product bottle may be absent of desiccant.
February 26, 2020DrugsFDA
American Health Packaging recalls Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by:
Hazard: GMP Deviations: Product bottle may be absent of desiccant.
February 26, 2020DrugsFDA
The Harvard Drug Group recalls Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured
Hazard: Failed Dissolution Specifications: High out of specification result observed at stability studies.
February 19, 2020DrugsFDA
GSK Consumer Health, Inc recalls Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcar
Hazard: Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.
February 19, 2020DrugsFDA
RemedyRepack Inc. recalls Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 1570
Hazard: Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
February 19, 2020DrugsFDA
Contract Pharmacal Corporation recalls Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 09
Hazard: Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
February 19, 2020DrugsFDA
Contract Pharmacal Corporation recalls Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardina
Hazard: Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
February 19, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuti
Hazard: Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
February 19, 2020DrugsFDA
American Health Packaging recalls Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: A
Hazard: Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
February 19, 2020DrugsFDA
AuroMedics Pharma LLC recalls Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma US
Hazard: Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
February 19, 2020DrugsFDA
Efficient Laboratories, Inc. recalls New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33
Hazard: Microbial Contamination of Non-Sterile Products
February 19, 2020DrugsFDA
Efficient Laboratories, Inc. recalls Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC
Hazard: Microbial Contamination of Non-Sterile Products
February 19, 2020DrugsFDA
Efficient Laboratories, Inc. recalls Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 3
Hazard: Microbial Contamination of Non-Sterile Products
February 19, 2020DrugsFDA
Par Pharmaceutical Inc. recalls Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Alm
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
February 19, 2020DrugsFDA
Pfizer Inc. recalls Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfize
Hazard: Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
February 19, 2020DrugsFDA
Pfizer Inc. recalls Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfize
Hazard: Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
February 19, 2020DrugsFDA
B AND A TRADING CORPORATION recalls Kushim Tablets (Gushim) 45-count packages, Label in foreign language
Hazard: Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
February 19, 2020DrugsFDA
Akorn Inc recalls Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityvill
Hazard: Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
February 19, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals
Hazard: CGMP deviations: Product bottle may be absent of desiccant.