Why it was recalled
Subpotent; 6 month stability time point
Product description
MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Lot numbers, UPCs & expiration codes
100 count: T147F13A, Exp. 05/2015; 21 count: S003M14, Exp. 05/2015
Where it was sold
Nationwide
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-1605-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 11, 2014
- FDA report date
- Oct 1, 2014
- Quantity
- 159,913 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1605-2014, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 69233
- Address
- 120 Vintage Dr NE
- Code information
- 100 count: T147F13A, Exp. 05/2015; 21 count: S003M14, Exp. 05/2015
- Postal code
- 35811-8216
- Report date
- Oct 1, 2014
- Product type
- Drugs
- Recall number
- D-1605-2014
- Classification
- Class III
- Recalling firm
- Qualitest Pharmaceuticals
- Product quantity
- 159,913 tablets
- Termination date
- Jan 27, 2016
- Reason for recall
- Subpotent; 6 month stability time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 11, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 22, 2014