Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
Reported: March 12, 2014 Initiated: January 24, 2014 #D-1092-2014
Product Description
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 10405 tablets
- Distribution
- Nationwide.
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.. Recalled by Teva Pharmaceuticals USA. Units affected: 10405 tablets.
Why was this product recalled? ▼
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 12, 2014. Severity: Moderate. Recall number: D-1092-2014.
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