Drug product
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.
D-826-2013
Product summary
- Event
- Event 65601
- Status
- Terminated
- Classification
- Class II
- Quantity
- 270 tablets
- Official record key
drug-enforcement:D-826-2013
Official wording
Reason: 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.
Code information: Lot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A
Distribution pattern: GA
Derived failure modes
-
Unknown
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.