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.
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.
Lot numbers, UPCs & expiration codes
Lot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A
Where it was sold
GA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-826-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 17, 2013
- FDA report date
- Aug 7, 2013
- Quantity
- 270 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Physicians Total Care, Inc.
Original FDA data
Every field from FDA enforcement report D-826-2013, exactly as published.
Show all FDA fields
- City
- Tulsa
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 65601
- Address
- 12515 E 55th St Ste 100
- Code information
- Lot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A
- Postal code
- 74146-6234
- Report date
- Aug 7, 2013
- Product type
- Drugs
- Recall number
- D-826-2013
- Classification
- Class II
- Recalling firm
- Physicians Total Care, Inc.
- Product quantity
- 270 tablets
- Termination date
- Aug 15, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- GA
- Recall initiation date
- Jun 17, 2013
- Initial firm notification
- FAX
- Center classification date
- Jul 26, 2013