July 24, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-1
Hazard: Failed Dissolution Specifications: results below specifications
July 24, 2024DrugsFDA
RemedyRepack Inc. recalls Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahw
Hazard: CGMP Deviations: Out of specification for dissolution
July 24, 2024DrugsFDA
Homeocare Laboratories, Inc. recalls STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 1
Hazard: Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
July 24, 2024DrugsFDA
Homeocare Laboratories, Inc. recalls STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street,
Hazard: Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
July 24, 2024DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Se
Hazard: This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
July 24, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenma
Hazard: CGMP Deviations
July 24, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenma
Hazard: CGMP Deviations
July 24, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenma
Hazard: Failed Dissolution Specifications
July 24, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenma
Hazard: Failed Dissolution Specifications
July 24, 2024DrugsFDA
Viatris Inc recalls Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig
Hazard: Failed Impurities/Degradation Specifications
July 24, 2024DrugsFDA
Viatris Inc recalls Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig
Hazard: Failed Impurities/Degradation Specifications
July 24, 2024DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., M
Hazard: Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
July 24, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphi
Hazard: Presence of particulate matter: glass
July 24, 2024DrugsFDA
Brands International Corporation recalls Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per ca
Hazard: Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
July 24, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laborato
Hazard: Failed Dissolution Specifications
July 17, 2024DrugsFDA
Rising Pharma Holding, Inc. recalls Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd
Hazard: Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
July 17, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 3
Hazard: Cross contamination with other products
July 17, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodar
Hazard: Cross contamination with other products
July 17, 2024DrugsFDA
TAILSTORM HEALTH INC recalls Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Com
Hazard: Subpotent Drug: reduced efficacy for epinephrine
July 17, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactur
Hazard: Cross contamination with other products.
July 17, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial
Hazard: Cross contamination with other products.
July 17, 2024DrugsFDA
Equibal Inc recalls Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plasti
Hazard: CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
July 17, 2024DrugsFDA
Amerisource Health Services LLC recalls buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only,
Hazard: Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
July 17, 2024DrugsFDA
SYNCHRONICITY SPA INC, DBA SUNTE recalls suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56
Hazard: CGMP Deviations
July 17, 2024DrugsFDA
SYNCHRONICITY SPA INC, DBA SUNTE recalls suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Sunt
Hazard: Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
July 17, 2024DrugsFDA
Baxter Healthcare Corporation recalls Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only
Hazard: Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
July 10, 2024DrugsFDA
Integrity Products recalls To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: I
Hazard: Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
July 10, 2024DrugsFDA
Integrity Products recalls RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Dis
Hazard: Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
July 10, 2024DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by:
Hazard: Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
July 10, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shrev
Hazard: Presence of foreign substance.