VersaPharm Ethambutol Tablets Recalled for Discoloration
West-ward Pharmaceutical Corp. is recalling VersaPharm Ethambutol Tablets USP 400 mg because the tablet cores may be discolored.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a cosmetic defect (discoloration) with no reported health hazards or injuries, fitting the criteria for a Low severity recall.
Plain-English summary
West-ward Pharmaceutical Corp. is recalling VersaPharm Ethambutol Tablets USP 400 mg. The recall is due to a defect where the tablet cores may be discolored.
The affected product is manufactured for VersaPharm Incorporated in Marietta, GA, and manufactured by West-ward Pharmaceutical Corp. in Eatontown, NJ. The recall covers 18,825 bottles distributed in Georgia. Specific lot codes and expiration dates are listed in the recall documentation.
Consumers should check their medication for the specific NDC codes and lot numbers associated with this recall. If the product matches the recalled description, patients should contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11 Manufactured for: VersaPharm Incorporated Marietta, GA…
- Manufacturer
- West-ward Pharmaceutical Corp.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 18,825
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 68977A
- 68977B
- 68978B
- 68978C
- 68979A - exp JUL 2015 68977C
- 68978A exp JUL 2013
Distribution
Distributed in 1 state:
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