Why it was recalled
Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life
Product description
Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Distributed by: Physicians Total Care Inc., Tulsa, OK 74146, NDC # 54868-2913-03
Lot numbers, UPCs & expiration codes
Lot # 5ASX, Exp 10/31/2011; 5O37; 5QSQ; 5T6J; 5U7Z; 5WIC; 5XDS; 5ZHY; 601J; 63MJ; 64O0, Exp. 02/28/2012.
Where it was sold
GA, PA
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-1391-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 18, 2011
- FDA report date
- Jul 4, 2012
- Quantity
- 60 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Physicians Total Care, Inc.
Original FDA data
Every field from FDA enforcement report D-1391-2012, exactly as published.
Show all FDA fields
- City
- Tulsa
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 62122
- Address
- 12515 E 55th St Ste 100
- Code information
- Lot # 5ASX, Exp 10/31/2011; 5O37; 5QSQ; 5T6J; 5U7Z; 5WIC; 5XDS; 5ZHY; 601J; 63MJ; 64O0, Exp. 02/28/2012.
- Postal code
- 74146-6234
- Report date
- Jul 4, 2012
- Product type
- Drugs
- Recall number
- D-1391-2012
- Classification
- Class II
- Recalling firm
- Physicians Total Care, Inc.
- Product quantity
- 60 bottles
- Termination date
- Feb 22, 2013
- Reason for recall
- Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Distributed by: Physicians Total Care Inc., Tulsa, OK 74146, NDC # 54868-2913-03
- Distribution pattern
- GA, PA
- Recall initiation date
- Mar 18, 2011
- Initial firm notification
- FAX
- Center classification date
- Jun 22, 2012