FDA-Drug2015-01-14Class III
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
Qualitest Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Sold states
Nationwide
Affected count
a) 3936 bottles; b) 84420 bottles
Manufactured in
120 Vintage Dr NE, N/A, Huntsville, AL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0331-2015Don't want to check this manually?
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