Class I - Dangerous
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
💊
Prescription Drugs
💊 Drugs • 11,927 recalls
Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Class I - Dangerous
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Class I - Dangerous
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Tuberculinum Bovinum, Potency: 12C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
Class I - Dangerous
cGMP deviations
Class I - Dangerous
Lack of assurance of sterility
Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
Class I - Dangerous
cGMP deviations
Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
Class I - Dangerous
cGMP deviations
Class I - Dangerous
Lack of assurance of sterility
Syphilinum, Potency: 9C, 30C, 200C, 10X, 12X, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
Class I - Dangerous
cGMP deviations
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
Lupin Pharmaceuticals
Class I - Dangerous
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Class I - Dangerous
Lack of assurance of sterility
Class I - Dangerous
Lack of assurance of sterility
Class I - Dangerous
Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.
Streptococcinum, Potency: 8C, 9C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
Class I - Dangerous
cGMP deviations
Diphtherinum, Potency: 14C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411,
Washington Homeopathic Products
Class I - Dangerous
cGMP deviations
Medorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
Class I - Dangerous
cGMP deviations
Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
Class I - Dangerous
cGMP deviations
Class I - Dangerous
Lack of assurance of sterility