Class I - Dangerous
Failed Impurities/Degradation Specifications
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
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.
Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6
Homeocare Laboratories
Class I - Dangerous
cGMP deviations
Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03
Ferring Pharmaceuticals
Class I - Dangerous
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
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
SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99
Homeocare Laboratories
Class I - Dangerous
cGMP deviations
Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01
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
Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01
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
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
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
Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02
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