Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.
Reported: April 10, 2013 Initiated: March 18, 2013 #D-242-2013
Product Description
Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.
Reason for Recall
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Details
- Recalling Firm
- West-ward Pharmaceutical Corp.
- Units Affected
- 3, 061 bottles
- Distribution
- Nationwide.
- Location
- Eatontown, NJ
Frequently Asked Questions
What product was recalled? ▼
Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.. Recalled by West-ward Pharmaceutical Corp.. Units affected: 3, 061 bottles.
Why was this product recalled? ▼
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 10, 2013. Severity: Moderate. Recall number: D-242-2013.
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