Class I - Dangerous
Lack of Assurance of Sterility
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.
Glenmark Therapeutics
Class I - Dangerous
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10
Dr Reddy's Laboratories Limited
Class I - Dangerous
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Failed Dissolution Specifications
SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10
New England Life Care, Inc.
Class I - Dangerous
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class I - Dangerous
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;
New England Life Care, Inc.
Class I - Dangerous
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
Global Pharma Healthcare Private Limited
Class I - Dangerous
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class I - Dangerous
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Presence of Particulate Matter: Particulate matter identified as fiber.
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
Global Pharma Healthcare Private Limited
Class I - Dangerous
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.