Qualitest Pharmaceuticals: Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

Agency Publication Date: October 21, 2014

Affected Products

Product: CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC

Codes: L049J12A, L067M12A, L079B13A, L079B13B, L077E13A, L010H13A, L011J13A, L101K13A

Product: CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0842-54, OTC

Codes: L084A13A, L095F13A, L027H13A, L102K13A

Product: CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0843-54, OTC

Codes: L084G12A, L097K12A, L001B13A, L001B13B, L079D13A, L102G13A, L007J13A

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69014

Status: Resolved

Manufacturer: Qualitest Pharmaceuticals

Manufactured In: United States

Units Affected: 3 products (181908 units; 101208 units; 170113 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Codes: L049J12A, L067M12A, L079B13A, L079B13B, L077E13A, L010H13A, L011J13A, L101K13A

Codes: L084A13A, L095F13A, L027H13A, L102K13A

Codes: L084G12A, L097K12A, L001B13A, L001B13B, L079D13A, L102G13A, L007J13A