drugs Class III Updated 2012-07-18

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals recalls HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bot

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: L072B11A, Exp 8/12; L102C11A, L103C11A, Exp 10/12; L046D11A, L082F11A, L089F11A, Exp 11/12; L148J11A, L149J11A, L150J11A, Exp 03/13; and L151J11A, Exp 04/13
View official government recall

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