July 19, 2023DrugsFDA
Global Pharma Healthcare Private Limited recalls Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distribut
Hazard: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
July 19, 2023DrugsFDA
Accord Healthcare, Inc. recalls Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27
Hazard: Presence of Particulate Matter: Particulate matter identified as fiber.
July 19, 2023DrugsFDA
Accord Healthcare, Inc. recalls Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: A
Hazard: Presence of Particulate Matter: Particulate matter identified as fiber.
July 19, 2023DrugsFDA
B. Braun Medical Inc. recalls 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-352
Hazard: Lack of assurance of sterility: bags have the potential to leak.
July 19, 2023DrugsFDA
Tenn South Distillery LLC dba Big Machine Distillery recalls Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distrib
Hazard: CGMP Deviation: impurities exceed allowable limits.
July 19, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 0
Hazard: Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
July 19, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippa
Hazard: Failed Moisture Limits: Water (moisture) content above the approved product specifications.
July 19, 2023DrugsFDA
L. Perrigo Company recalls Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-cou
Hazard: Failed Impurities/Degradation Specifications
July 19, 2023DrugsFDA
L. Perrigo Company recalls Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc
Hazard: Failed Impurities/Degradation Specifications
July 19, 2023DrugsFDA
L. Perrigo Company recalls allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-coun
Hazard: Failed Impurities/Degradation Specifications
July 19, 2023DrugsFDA
L. Perrigo Company recalls allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-
Hazard: Failed Impurities/Degradation Specifications
July 19, 2023DrugsFDA
L. Perrigo Company recalls Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons
Hazard: Failed Impurities/Degradation Specifications
July 19, 2023DrugsFDA
L. Perrigo Company recalls Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847
Hazard: Failed Impurities/Degradation Specifications
July 19, 2023DrugsFDA
L. Perrigo Company recalls allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-coun
Hazard: Failed Impurities/Degradation Specifications
July 19, 2023DrugsFDA
L. Perrigo Company recalls Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave.
Hazard: Failed Impurities/Degradation Specifications
July 19, 2023DrugsFDA
L. Perrigo Company recalls aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchanges, By: Per
Hazard: Failed Impurities/Degradation Specifications
July 19, 2023DrugsFDA
L. Perrigo Company recalls Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CV
Hazard: Failed Impurities/Degradation Specifications
July 19, 2023DrugsFDA
L. Perrigo Company recalls Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, S
Hazard: Failed Impurities/Degradation Specifications
July 19, 2023DrugsFDA
L. Perrigo Company recalls Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale
Hazard: Failed Impurities/Degradation Specifications
July 19, 2023DrugsFDA
L. Perrigo Company recalls Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count
Hazard: Failed Impurities/Degradation Specifications
July 19, 2023DrugsFDA
Lupin Pharmaceuticals Inc. recalls Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Balti
Hazard: Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
July 19, 2023DrugsFDA
K.C. Pharmaceuticals, Inc recalls Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) bo
Hazard: CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
July 19, 2023DrugsFDA
K.C. Pharmaceuticals, Inc recalls Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formul
Hazard: CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
July 19, 2023DrugsFDA
Vivus, Inc. recalls PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campb
Hazard: Failed Stability Specifications
July 12, 2023DrugsFDA
Strides Pharma Inc. recalls Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Scie
Hazard: Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
July 12, 2023DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-
Hazard: Failed Stability Specifications
July 12, 2023DrugsFDA
Amerisource Health Services LLC recalls Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and D
Hazard: Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
July 5, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury,
Hazard: Subpotent drug
July 5, 2023DrugsFDA
Homeocare Laboratories, Inc. recalls StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 696
Hazard: cGMP deviations
July 5, 2023DrugsFDA
Homeocare Laboratories, Inc. recalls StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02
Hazard: cGMP deviations