PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: October 1, 2014 Initiated: September 11, 2014 #D-1605-2014

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

Reason for Recall

Subpotent; 6 month stability time point

Details

Recalling Firm
Qualitest Pharmaceuticals
Units Affected
159,913 tablets
Distribution
Nationwide
Location
Huntsville, AL

Frequently Asked Questions

What product was recalled?
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. Recalled by Qualitest Pharmaceuticals. Units affected: 159,913 tablets.
Why was this product recalled?
Subpotent; 6 month stability time point
Which agency issued this recall?
This recall was issued by the FDA Drug on October 1, 2014. Severity: Low. Recall number: D-1605-2014.