Class II
Terminated
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.
This recall has been terminated (originally issued August 7, 2013).
- Company
- Physicians Total Care, Inc.
- Recall Initiated
- June 17, 2013
- Posted
- August 7, 2013
- Recall Number
- D-826-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 270 tablets
- Firm Location
- Tulsa, OK, United States
- Official Source
- View on FDA website ↗
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
GA
Lot / Code Info
Lot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A
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