Status
Terminated
Drug Enforcement D-826-2013
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.
Classification
Class II
Report Date
August 7, 2013
Termination Date
August 15, 2013
Product Information
- 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.
- Product quantity
- 270 tablets
- 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.
- Recall initiation reason
- —
- Initial firm notification
- FAX
- Distribution pattern
- GA
Location & Firm
- Recalling firm
- Physicians Total Care, Inc.
- Address
-
12515 E 55th St Ste 100, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-826-2013
- Event ID
- 65601
- Recall initiation date
- June 17, 2013
- Center classification date
- July 26, 2013
- Code info
- Lot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A
- More code info
- —