Class II
Terminated
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- January 24, 2014
- Posted
- March 12, 2014
- Recall Number
- D-1092-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10405 tablets
- Firm Location
- Horsham, PA, United States
Reason for Recall
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
Distribution
Nationwide.
Lot / Code Info
Lot # 34013698A, Exp. 01/16. Lot # 34013699A, Exp. 01/16. Lot # 34013700A, Exp. 01/16. Lot # 34013756A, Exp. 01/16.
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