Class III
Terminated
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.
- Recall Initiated
- July 6, 2012
- Posted
- July 18, 2012
- Recall Number
- D-1411-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 54,431 bottles
- Firm Location
- Huntsville, AL, United States
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.
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
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