FDA-Drug2012-07-18Class III
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.
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Hazard
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Sold states
Nationwide and Puerto Rico.
Affected count
54,431 bottles
Manufactured in
120 Vintage Dr NE, Huntsville, AL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1411-2012Don't want to check this manually?
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