The Recall Desk
LowFDA (Drugs)·D-839-2013·Announced 2013-08-14

West-Ward Recalls Ethambutol Hydrochloride Tablets Due to Surface Ink Defects

West-Ward Pharmaceutical Corp. is recalling 118 bottles of Ethambutol Hydrochloride Tablets 400 mg due to out-of-specification surface ink defects.

What this means for you

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 surface defect (ink) with no reported health risks or injuries, fitting the criteria for a Low severity recall.

Plain-English summary

West-Ward Pharmaceutical Corp. is recalling 118 bottles of Ethambutol Hydrochloride Tablets, USP 400 mg, 60-count bottles. The product is manufactured for VersaPharm Incorporated and is identified by NDC 61748-014-06, Lot 69968B, with an expiration date of 03/14.

The recall was initiated because the tablets failed description testing due to an out-of-specification surface defect involving ink. The affected units were distributed in Georgia.

Consumers and healthcare providers should check their inventory for this specific lot and NDC number. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement, or disposed of according to local regulations.

The recalled product

Product
VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,
Manufacturer
West-Ward Pharmaceutical Corp.
Category
Drug — Prescription Medication
Hazard
Affected units
118

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 (1)

  • Lot 69968B 03/14

Distribution

Distributed in 1 state:

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