D-826-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 7, 2013
- Initiation Date
- June 17, 2013
- Termination Date
- August 15, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 270 tablets
Product Description
Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146.
Reason for Recall
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
Distribution Pattern
GA
Code Information
Lot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A