Drug Enforcement D-883-2013

Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets

Status

Terminated

Classification

Class II

Report Date

August 21, 2013

Termination Date

June 23, 2014

Product Information

Product description
Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724.
Product quantity
1000 count bottles/61,370 and 5000 count bottles/321
Reason for recall
Presence of Foreign Substance: black specks comprised of degraded organic material found 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

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

Codes & Dates

Recall number
D-883-2013
Event ID
65844
Recall initiation date
July 30, 2013
Center classification date
August 12, 2013
Code info
1000's: Catalog #1140-10; Lot #/Expiry Dates: 67328A; 67329A; 67330B; 67330C/Dec 2013; 68064B; 68065A/Jan 2014; 68666B; 68667A/May 2015; 69721A/Dec 2015 and 69722A/Jan 2016. 5000's: Catalog #1140-51; Lot #/Expiry Dates: 68064A/Jan 2015 and 68666A/May 2015.
More code info
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