Class II · Moderate risk Ongoing
Clindamycin Palmitate Hydrochloride for Oral Solution
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
What was recalled
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta, GA 30065-1509 Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 61748-011-01
- Recalling firm
- West-Ward Pharmaceutical Corp.
- NDC code
- 61748-011-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0172-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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