The Recall Desk
LowFDA (Drugs)·D-164-2013·Announced 2013-02-20

West-ward Recalls Subpotent Glycopyrrolate Tablets in Ohio

West-ward Pharmaceutical Corp. voluntarily recalled 1,185 bottles of Glycopyrrolate Tablets, USP, 1 mg, in Ohio due to subpotent drug content.

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 FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for minor issues.

Plain-English summary

West-ward Pharmaceutical Corp. has voluntarily recalled 1,185 bottles of Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle. The recall was initiated on January 7, 2013, and the product was distributed in Ohio. The specific lot number is 69001A, and the NDC is 0143-1250-01.

The reason for the recall is that the tablets were found to be subpotent, meaning they did not contain the full amount of the active ingredient as labeled. The FDA classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers who have this product should contact their healthcare provider or pharmacist for guidance. The recall was terminated on May 16, 2014.

The recalled product

Product
Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01.
Affected units
1,185

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 #: 69001A

Distribution

Distributed in 1 state: