Drug Enforcement D-242-2013

Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.

Status

Terminated

Classification

Class II

Report Date

April 10, 2013

Termination Date

December 18, 2013

Product Information

Product description
Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.
Product quantity
3, 061 bottles
Reason for recall
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide.

Location & Firm

Recalling firm
West-ward Pharmaceutical Corp.
Address
465 Industrial Way W, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-242-2013
Event ID
64821
Recall initiation date
March 18, 2013
Center classification date
April 3, 2013
Code info
Lot #: 68028A, Exp 07/14
More code info
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