FDAFDA · Food and drugs·Recall number D-826-2013
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.
Published August 7, 2013 · Recall initiated: June 17, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · FAX
Recall details
- Manufacturer
- Physicians Total Care, Inc.
- Distributor
- GA
- Lot
- Lot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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