Recalls / Class II
Class IID-1092-2014
Product
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
- Affected lot / code info
- Lot # 34013698A, Exp. 01/16. Lot # 34013699A, Exp. 01/16. Lot # 34013700A, Exp. 01/16. Lot # 34013756A, Exp. 01/16.
Why it was recalled
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 10405 tablets
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-01-24
- FDA classified
- 2014-02-28
- Posted by FDA
- 2014-03-12
- Terminated
- 2014-10-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1092-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.