February 10, 2021DrugsFDA
Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
February 10, 2021DrugsFDA
AuroMedics Pharma LLC recalls Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed b
Hazard: Discoloration and failed pH specifications
February 10, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:
Hazard: Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
February 10, 2021DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2
Hazard: CGMP deviations.
February 3, 2021DrugsFDA
Fresenius Kabi USA, LLC recalls Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Si
Hazard: Presence of Particulate Matter - found in reserve sample vials at the firm.
February 3, 2021DrugsFDA
Bausch Health Companies, Inc. recalls Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant P
Hazard: Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
February 3, 2021DrugsFDA
Bausch Health Companies, Inc. recalls Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America,
Hazard: Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
February 3, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun
Hazard: Incorrect Labeling: Incorrect lot number on secondary packaging
February 3, 2021DrugsFDA
Shane Erickson Inc recalls IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Made in China, Distributed by IMC 4284 Shorel
Hazard: CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
February 3, 2021DrugsFDA
Shane Erickson Inc recalls IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreli
Hazard: CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
February 3, 2021DrugsFDA
Shane Erickson Inc recalls IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottles, Distributed by IMC 4284 Shoreline Dr, S
Hazard: CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
January 27, 2021DrugsFDA
Edge Pharma, LLC recalls Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. K
Hazard: Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
January 27, 2021DrugsFDA
Complete Pharmacy and Medical Solutions, LLC. recalls HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyo
Hazard: CGMP deviations: Lack of potency testing.
January 27, 2021DrugsFDA
Complete Pharmacy and Medical Solutions, LLC. recalls HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyo
Hazard: CGMP deviations: Lack of potency testing.
January 27, 2021DrugsFDA
Complete Pharmacy and Medical Solutions, LLC. recalls HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyo
Hazard: CGMP deviations: Lack of potency testing.
January 27, 2021DrugsFDA
Complete Pharmacy and Medical Solutions, LLC. recalls HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Ly
Hazard: CGMP deviations: Lack of potency testing.
January 27, 2021DrugsFDA
Allergan, PLC. recalls Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie
Hazard: Labeling: Missing instructions for use insert
January 27, 2021DrugsFDA
American Health Packaging recalls Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx onl
Hazard: Failed Dissolution Specifications
January 20, 2021DrugsFDA
Genus Lifesciences Inc. recalls Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Ca
Hazard: Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
January 20, 2021DrugsFDA
GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION recalls Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A
Hazard: cGMP deviations: Product made at the same facility where product tested was sub-potent.
January 20, 2021DrugsFDA
GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION recalls Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal
Hazard: cGMP deviations: Product made at the same facility where product tested was sub-potent.
January 20, 2021DrugsFDA
Precision Dose Inc. recalls Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61,
Hazard: cGMP deviations: The firm was notified of the manufacturer's expanded recall.
January 20, 2021DrugsFDA
Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
January 20, 2021DrugsFDA
Edge Pharma, LLC recalls Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRI
Hazard: Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
January 20, 2021DrugsFDA
KVK-Tech, Inc. recalls Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., N
Hazard: Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
January 20, 2021DrugsFDA
US Compounding Inc recalls Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conw
Hazard: Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
January 20, 2021DrugsFDA
Sunstar Americas, Inc. recalls Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-
Hazard: cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
January 20, 2021DrugsFDA
Akorn, Inc. recalls Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 1
Hazard: Defective container: Customer complaints for oral solution leaking from bottles.
January 13, 2021DrugsFDA
SCA Pharmaceuticals recalls Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuti
Hazard: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
January 13, 2021DrugsFDA
SCA Pharmaceuticals recalls PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceutic
Hazard: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit