July 5, 2023DrugsFDA
Homeocare Laboratories, Inc. recalls StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-0
Hazard: cGMP deviations
July 5, 2023DrugsFDA
Homeocare Laboratories, Inc. recalls StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-
Hazard: cGMP deviations
July 5, 2023DrugsFDA
Homeocare Laboratories, Inc. recalls StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL N
Hazard: cGMP deviations
July 5, 2023DrugsFDA
Homeocare Laboratories, Inc. recalls SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99
Hazard: cGMP deviations
July 5, 2023DrugsFDA
Homeocare Laboratories, Inc. recalls DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
Hazard: cGMP deviations
July 5, 2023DrugsFDA
Homeocare Laboratories, Inc. recalls Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC
Hazard: cGMP deviations
July 5, 2023DrugsFDA
Homeocare Laboratories, Inc. recalls Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758
Hazard: cGMP deviations
July 5, 2023DrugsFDA
Homeocare Laboratories, Inc. recalls Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6
Hazard: cGMP deviations
July 5, 2023DrugsFDA
Homeocare Laboratories, Inc. recalls Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY ND
Hazard: cGMP deviations
July 5, 2023DrugsFDA
Ferring Pharmaceuticals Inc recalls Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal ap
Hazard: cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
July 5, 2023DrugsFDA
The Harvard Drug Group recalls Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Indu
Hazard: Packaging defect: blister packaging inadequately sealed.
June 28, 2023DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limit
Hazard: Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
June 28, 2023DrugsFDA
Aurolife Pharma, LLC recalls Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor,
Hazard: Failed Impurities/Degradation Specifications
June 21, 2023DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceutical
Hazard: Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
June 21, 2023DrugsFDA
AVKARE LLC recalls Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, N
Hazard: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
June 21, 2023DrugsFDA
Jarman's Midwest Cleaning Systems, Inc. recalls SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon
Hazard: Chemical Contamination: FDA testing found Presence of methanol
June 21, 2023DrugsFDA
Jarman's Midwest Cleaning Systems, Inc. recalls Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle,
Hazard: Chemical Contamination: FDA testing found Presence of methanol
June 21, 2023DrugsFDA
Jarman's Midwest Cleaning Systems, Inc. recalls Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon
Hazard: CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
June 21, 2023DrugsFDA
Amring Pharmaceuticals Inc recalls Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals
Hazard: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
June 14, 2023DrugsFDA
HF Acquisition Co LLC recalls GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-
Hazard: Labeling: Label Mix-up
June 14, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
Hazard: CGMP Deviations
June 14, 2023DrugsFDA
Golden State Medical Supply Inc. recalls Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactur
Hazard: Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
June 14, 2023DrugsFDA
Viatris Inc recalls Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampul
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.
June 14, 2023DrugsFDA
Empower Clinic Services LLC dba Empower Pharmacy recalls ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower
Hazard: Mislabeling: preservative free product labeled as preserved.
June 7, 2023DrugsFDA
Novis PR, LLC dba Kramer Novis recalls G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal
Hazard: Product mix-up: incorrect product was found inside the G-Supress DX product carton.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee,
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc.
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.