Drug Enforcement D-170-2013

Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.

Status

Terminated

Classification

Class II

Report Date

March 6, 2013

Termination Date

January 21, 2015

Product Information

Product description
Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724
Product quantity
6,511 bottles
Reason for recall
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
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-170-2013
Event ID
64107
Recall initiation date
January 7, 2013
Center classification date
February 27, 2013
Code info
Lot #: 69099A, 69099B, Exp 08/15
More code info
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