FDA Drug Recalls

Recalls / Class III

Class IIID-164-2013

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 lot / code info
Lot #: 69001A

Why it was recalled

Subpotent Drug

Recalling firm

Firm
West-ward Pharmaceutical Corp.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
465 Industrial Way W, Eatontown, New Jersey 07724-2209

Distribution

Quantity
1,185 Bottles
Distribution pattern
OH

Timeline

Recall initiated
2013-01-07
FDA classified
2013-02-12
Posted by FDA
2013-02-20
Terminated
2014-05-16
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-164-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.