CLASS II Drug recall · Reported 7 Aug 2013 · FDA Enforcement Report
Belladonna Alkaloids/PB (Belladonna Alkaloids recalled
Physicians Total Care is recalling Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP, distributed in Georgia. The recall was initiated on 17 Jun 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-826-2013
- FDA event ID
- 65601
- Recalling firm
- Physicians Total Care, Tulsa, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jun 2013
- FDA classified
- 26 Jul 2013
- Reported
- 7 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- FAX
- Reason category
- Packaging Defects
Timeline
| 17 Jun 2013 | Recall initiated by company | |
| 26 Jul 2013 | Classified by FDA | +39 days |
| 7 Aug 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
GA
Questions about this recall
Why was it 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.
Which lots are affected?
Lot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A
Where was it sold?
GA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Physicians Total Care
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cephalexin Monohydrate Capsules,USP, 500 mg recalled | Physicians Total Care | Manufacturing (CGMP) Deviations | GA, MO |
| Drug | CLASS III | Loratadine 24 HR recalled by Physicians Total Care | Physicians Total Care | Other | Nationwide |
| Drug | CLASS II | Carisoprodol IV ( Carisoprodol Tablets USP) 350mg recalled | Physicians Total Care | Lead & Heavy Metals | 4 states |
| Drug | CLASS III | Voltaren 1% Gel, 100 gm tube recalled by Physicians Total Care | Physicians Total Care | Other | Nationwide |
| Drug | CLASS II | Metronidazole Tablets, USP, 500 mg recalled by Physicians Total Care | Physicians Total Care | Packaging Defects | Nationwide |
Other Belladonna Alkaloids recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Belladonna Alkaloids with Phenobarbital Tablets recalled | West-Ward Pharmaceutical | Other | Nationwide |