FDA recall D-826-2013

Physicians Total Care, Inc. · Class II · drug

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.

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

Key facts

Status: Terminated
Initiation date: 2013-06-17
Report date: 2013-08-07
Termination date: 2013-08-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tulsa, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-826-2013