FDA Drug Recalls

Recalls / Class II

Class IID-825-2013

Product

West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724

Affected lot / code info
Lot# 67331A, Exp 10/14

Why it was recalled

Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.

Recalling firm

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

Distribution

Quantity
7,324 bottles
Distribution pattern
Nationwide

Timeline

Recall initiated
2013-05-16
FDA classified
2013-07-25
Posted by FDA
2013-07-31
Terminated
2014-06-23
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-825-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls