Recall record at a glance
| Official record | D-826-2013 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Physicians Total Care, Inc. |
| Report date | Aug 7, 2013 |
| Recall initiation date | Jun 17, 2013 |
| Quantity | 270 tablets |
| Location | Tulsa, OK, United States |
Official 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.
Why the product 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.
Distribution information
GA
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: FAX.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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