D-826-2013 Class II Terminated
FDA drug recall D-826-2013 was initiated by Physicians Total Care, Inc. on June 17, 2013 and is designated Class II. 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. The recall status is terminated (terminated August 15, 2013). Affected quantity: 270 tablets.
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