FDA recall D-0859-2017
Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals · Class III · drug
Product
HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.
Reason for recall
Superpotent Drug: above specification for the assay.
Distribution
Nationwide in the USA and Puerto Rico.
Key facts
- Status
- Terminated
- Initiation date
- 2017-05-08
- Report date
- 2017-05-31
- Termination date
- 2018-05-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Huntsville, AL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0859-2017