Reported Jan 14, 2015 · Terminated
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles,…
Qualitest Pharmaceuticals
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qualitest Pharmaceuticals · 120 Vintage Dr NE · Huntsville, AL · 35811-8216
Is this the product you have?
- 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 forQUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
- Lot codes and dates
Lot #: a) L140H13BExp. 03/15L001D14A. Exp. 08/15b) L140H13AExp. 03/15L205K13AExp. 05/15L019L13AL020L13AExp. 06/15L001D14B08/15L091D14AExp. 10/15
- Amount recalled
- a) 3936 bottles; b) 84420 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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