Drug Enforcement D-824-2013

Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.

Status

Terminated

Classification

Class II

Report Date

July 31, 2013

Termination Date

June 23, 2014

Product Information

Product description
West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724
Product quantity
14,503 bottles
Reason for recall
Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on 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-824-2013
Event ID
65445
Recall initiation date
May 16, 2013
Center classification date
July 25, 2013
Code info
Lot # 69098A, 69098B, 69100A; Exp 8/15
More code info
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