Recalls / Class II
Class IID-826-2013
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.
- Affected lot / code info
- Lot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A
Why it was recalled
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.
Recalling firm
- Firm
- Physicians Total Care, Inc.
- Notification channel
- FAX
- Type
- Voluntary: Firm initiated
- Address
- 12515 E 55th St Ste 100, N/A, Tulsa, Oklahoma 74146-6234
Distribution
- Quantity
- 270 tablets
- Distribution pattern
- GA
Timeline
- Recall initiated
- 2013-06-17
- FDA classified
- 2013-07-26
- Posted by FDA
- 2013-08-07
- Terminated
- 2013-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-826-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.