Recalls / Class III
Class IIID-0331-2015
Product
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
- Affected 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
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Recalling firm
- Firm
- Qualitest Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 120 Vintage Dr NE, N/A, Huntsville, Alabama 35811-8216
Distribution
- Quantity
- a) 3936 bottles; b) 84420 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-12-22
- FDA classified
- 2015-01-06
- Posted by FDA
- 2015-01-14
- Terminated
- 2016-02-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0331-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.