December 4, 2024DrugsFDA
Unexo Life Sciences Private Limited recalls ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 pa
Hazard: cGMP Deviations
December 4, 2024DrugsFDA
Unexo Life Sciences Private Limited recalls ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, T
Hazard: cGMP Deviations
December 4, 2024DrugsFDA
Unexo Life Sciences Private Limited recalls ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chatt
Hazard: cGMP Deviations
November 27, 2024DrugsFDA
Evaric Pharmaceuticals Inc. recalls Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactu
Hazard: Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
November 27, 2024DrugsFDA
Safecor Health, LLC recalls Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-0
Hazard: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
November 27, 2024DrugsFDA
Safecor Health, LLC recalls Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 4
Hazard: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
November 27, 2024DrugsFDA
Safecor Health, LLC recalls Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433
Hazard: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
November 27, 2024DrugsFDA
Safecor Health, LLC recalls Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01
Hazard: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
November 27, 2024DrugsFDA
Safecor Health, LLC recalls Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01
Hazard: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
November 27, 2024DrugsFDA
Noven Pharmaceuticals Inc recalls Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal p
Hazard: Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
November 27, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180
Hazard: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
November 27, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-
Hazard: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
November 27, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 6818
Hazard: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
November 27, 2024DrugsFDA
Tailstorm Health INC recalls BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Heal
Hazard: Lack of Sterility Assurance
November 27, 2024DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapo
Hazard: Failed Impurity/Degradation Specifications
November 27, 2024DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianap
Hazard: Failed Impurity/Degradation Specifications
November 27, 2024DrugsFDA
Padagis US LLC recalls Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427
Hazard: Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
November 27, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08
Hazard: Failed Tablet/Capsule Specifications
November 20, 2024DrugsFDA
Keystone Industries recalls Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint fla
Hazard: Subpotent Drug
November 20, 2024DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Bru
Hazard: Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
November 20, 2024DrugsFDA
Cipla USA, Inc. recalls Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 762
Hazard: Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
November 20, 2024DrugsFDA
Cipla USA, Inc. recalls Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
Hazard: Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
November 20, 2024DrugsFDA
Trinity Gold Nutrition recalls Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, For
Hazard: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
November 13, 2024DrugsFDA
Direct Rx recalls Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT
Hazard: Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
November 13, 2024DrugsFDA
Staska Pharmaceuticals, Inc. recalls Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergr
Hazard: Presence of Particulate Matter: Presence of glass particulates.
November 13, 2024DrugsFDA
Baxter Healthcare Corporation recalls Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Ph
Hazard: Labeling: Missing Label
November 13, 2024DrugsFDA
VIONA PHARMACEUTICALS INC recalls Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Vio
Hazard: Crystallization
November 13, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville,
Hazard: Failed Impurities/Degradation Specification
November 13, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenvill
Hazard: Failed Impurities/Degradation Specification
November 13, 2024DrugsFDA
FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran
Hazard: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle