Recalls / Class III
Class IIID-1605-2014
Product
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
- Brand name
- Methylprednisolone
- Generic name
- Methylprednisolone
- Active ingredient
- Methylprednisolone
- Route
- Oral
- NDC
- 0603-4593
- FDA application
- ANDA040183
- Affected lot / code info
- 100 count: T147F13A, Exp. 05/2015; 21 count: S003M14, Exp. 05/2015
Why it was recalled
Subpotent; 6 month stability time point
Recalling firm
- Firm
- Qualitest Pharmaceuticals
- Manufacturer
- Endo USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 120 Vintage Dr NE, N/A, Huntsville, Alabama 35811-8216
Distribution
- Quantity
- 159,913 tablets
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-09-11
- FDA classified
- 2014-09-22
- Posted by FDA
- 2014-10-01
- Terminated
- 2016-01-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1605-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.