May 24, 2023DrugsFDA
Astral SteriTech Private Ltd. recalls Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA,
Hazard: Lack of Assurance of Sterility
May 24, 2023DrugsFDA
Astral SteriTech Private Ltd. recalls Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, I
Hazard: Lack of Assurance of Sterility
May 24, 2023DrugsFDA
Astral SteriTech Private Ltd. recalls Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL
Hazard: Lack of Assurance of Sterility
May 24, 2023DrugsFDA
Astral SteriTech Private Ltd. recalls Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove
Hazard: Lack of Assurance of Sterility
May 24, 2023DrugsFDA
Astral SteriTech Private Ltd. recalls Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grov
Hazard: Lack of Assurance of Sterility
May 24, 2023DrugsFDA
Astral SteriTech Private Ltd. recalls Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18
Hazard: Lack of Assurance of Sterility
May 24, 2023DrugsFDA
Astral SteriTech Private Ltd. recalls Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-
Hazard: Lack of Assurance of Sterility
May 24, 2023DrugsFDA
Astral SteriTech Private Ltd. recalls Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-
Hazard: Lack of Assurance of Sterility
May 24, 2023DrugsFDA
Astral SteriTech Private Ltd. recalls Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66
Hazard: Lack of Assurance of Sterility
May 24, 2023DrugsFDA
Astral SteriTech Private Ltd. recalls Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66
Hazard: Lack of Assurance of Sterility
May 24, 2023DrugsFDA
B. Braun Medical Inc recalls Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B.
Hazard: Subpotent: Low anti-factor IIa Potency.
May 24, 2023DrugsFDA
RemedyRepack Inc. recalls Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-25
Hazard: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
May 24, 2023DrugsFDA
RemedyRepack Inc. recalls Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: Remed
Hazard: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
May 24, 2023DrugsFDA
RemedyRepack Inc. recalls LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: Remedy
Hazard: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
May 24, 2023DrugsFDA
Sanofi-Aventis U.S. LLC recalls Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewa
Hazard: Lack of Assurance of Sterility: Malformed crimped collar seal
May 24, 2023DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
May 17, 2023DrugsFDA
The Harvard Drug Group recalls Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distribu
Hazard: Product mixup: one foreign tablet found in product.
May 17, 2023DrugsFDA
Apotex Corp. recalls Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/s
Hazard: Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
May 17, 2023DrugsFDA
Camber Pharmaceuticals Inc. recalls Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc.,
Hazard: Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
May 10, 2023DrugsFDA
Gadget Island, Inc recalls DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
Hazard: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
May 10, 2023DrugsFDA
Gadget Island, Inc recalls NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
Hazard: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
May 10, 2023DrugsFDA
Gadget Island, Inc recalls Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98
Hazard: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
May 10, 2023DrugsFDA
Family Dollar Stores, Llc. recalls Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Ca
Hazard: CGMP deviation: product outside labeled storage temperature requirements.
May 10, 2023DrugsFDA
Family Dollar Stores, Llc. recalls Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplet
Hazard: CGMP deviation: product outside labeled storage temperature requirements.
May 10, 2023DrugsFDA
Family Dollar Stores, Llc. recalls Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets
Hazard: CGMP deviation: product outside labeled storage temperature requirements.
May 10, 2023DrugsFDA
Family Dollar Stores, Llc. recalls Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottle
Hazard: CGMP deviation: product outside labeled storage temperature requirements.
May 10, 2023DrugsFDA
Seatex LLC recalls Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Cont
Hazard: Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
May 10, 2023DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated
Hazard: CGMP deviations.
May 10, 2023DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated
Hazard: CGMP deviations.
May 10, 2023DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklaho
Hazard: CGMP deviations.