Class III
Terminated
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
- Company
- Qualitest Pharmaceuticals
- Recall Initiated
- December 22, 2014
- Posted
- January 14, 2015
- Recall Number
- D-0331-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 3936 bottles; b) 84420 bottles
- Firm Location
- Huntsville, AL, United States
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Distribution
Nationwide
Lot / Code Info
Lot #: a) L140H13B, Exp. 03/15; L001D14A. Exp. 08/15; b) L140H13A, Exp. 03/15; L205K13A, Exp. 05/15; L019L13A, L020L13A, Exp. 06/15; L001D14B, 08/15; L091D14A, Exp. 10/15
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