Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Class I - Dangerous
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Class I - Dangerous
Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.
Class I - Dangerous
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
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
Colibacillinum, Potency: 12C, 14C, 15C, 18C, 20C, 30C, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
Class I - Dangerous
cGMP deviations
Anthracinum, Potency: 6C, 7C, 8C, 9C, 12C, 14C, 30C, 200C, 11X, 14X, 30X Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way Berkeley Springs, WV 25411
Washington Homeopathic Products
Class I - Dangerous
cGMP deviations
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
Proteus, Potency: 7C, 8C, 9C, 12C, 15C, 16C, 20C, 30C, 200C, OTC, Liquid Pellets, 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