FDA recall D-1411-2012

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals · Class III · drug

Product

HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.

Reason for recall

Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.

Distribution

Nationwide and Puerto Rico.

Key facts

Status: Terminated
Initiation date: 2012-07-06
Report date: 2012-07-18
Termination date: 2013-02-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1411-2012