Teva Ethambutol Hydrochloride Tablets recall: CGMP Deviations
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC…
Why was Teva Ethambutol Hydrochloride Tablets recalled?
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 34013698A, Exp. 01/16. Lot # 34013699A, Exp. 01/16. Lot # 34013700A, Exp. 01/16. Lot # 34013756A, Exp. 01/16.
- Product
- Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC…
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 10405 tablets
- Distribution
- Nationwide.
- Recall date
- March 12, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)