Class I - Dangerous
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Failed Stability Specifications
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2.
Amerisource Health Services
Class I - Dangerous
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Class I - Dangerous
Packaging defect: blister packaging inadequately sealed.
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16
Homeocare Laboratories
Class I - Dangerous
cGMP deviations
Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Subpotent drug
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01
Homeocare Laboratories
Class I - Dangerous
cGMP deviations
StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02
Homeocare Laboratories
Class I - Dangerous
cGMP deviations
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16
Homeocare Laboratories
Class I - Dangerous
cGMP deviations
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02
Homeocare Laboratories
Class I - Dangerous
cGMP deviations
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08
The Harvard Drug Group LLC
Class I - Dangerous
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.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
Amneal Pharmaceuticals of New York
Class I - Dangerous
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30
Amring Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
CGMP Deviations
ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1
Empower Clinic Services LLC
Class I - Dangerous
Mislabeling: preservative free product labeled as preserved.
Class I - Dangerous
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.
Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incorporated, Camarillo, CA 93012, a) NDC 51407-731-25 (2.5 mL bottle), b) NDC 51407-731-05 (5 mL bottle).
Golden State Medical Supply
Class I - Dangerous
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3
HF Acquisition Co
Class I - Dangerous
Labeling: Label Mix-up