The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0037-2015·Announced 2014-10-29

Qualitest Recalls Children's Acetaminophen Suspension for Assay Failure

Qualitest Pharmaceuticals is recalling Children's Q-PAP Acetaminophen Oral Suspension because the product failed an assay test at the 12-month timepoint.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly labels the issue as a 'Superpotent Drug' recall, which involves a significant deviation from the intended drug strength. Per the rubric, significant injury or property damage reports, or high-risk deviations like superpotency, align with a Severe (4) classification, especially given the FDA Class II designation which implies potential for temporary or reversible harm.

Plain-English summary

Qualitest Pharmaceuticals is initiating a recall of Children's Q-PAP, Acetaminophen, Oral Suspension, Bubble Gum Flavor. The product is an over-the-counter liquid medication containing 160 mg of acetaminophen per 5 mL, distributed nationwide in 4 FL OZ (118 mL) bottles.

The recall was initiated due to a failure of the product assay at the 12-month timepoint. The source text identifies this as a "Superpotent Drug" issue, indicating the medication may contain higher levels of the active ingredient than intended. The recall covers specific lot codes: L049J12A, L067M12A, L079B13A, L079B13B, L077E13A, L010H13A, L011J13A, and L101K13A.

Consumers should check their bottles for the affected lot codes and stop using the product if it matches. The FDA has classified this as a Class II recall, which means the product may cause temporary or medically reversible health problems, or where the probability of serious adverse health consequences is remote.

The recalled product

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
Manufacturer
Qualitest Pharmaceuticals
Category
Drug — Over-the-Counter Medication
Hazard
Affected units
181,908

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Qualitest Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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