FDA recall D-1605-2014

Qualitest Pharmaceuticals · Class III · drug

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

Reason for recall

Subpotent; 6 month stability time point

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-09-11
Report date: 2014-10-01
Termination date: 2016-01-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1605-2014