The Recall Desk
SevereFDA (Drugs)·D-0038-2015·Announced 2014-10-29

Qualitest Recalls Children's Acetaminophen Suspension for Assay Failure

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

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the product as a 'Superpotent Drug' and the agency classification is Class II. Per the rubric, FDA Class II recalls involving significant risks or specific high-risk classifications like superpotent drugs are rated as Severe (4).

Plain-English summary

Qualitest Pharmaceuticals is initiating a recall of Children's Q-PAP, Acetaminophen, Oral Suspension, Cherry Flavor. The product is an over-the-counter liquid medication containing 160 mg of acetaminophen per 5 mL. The recall involves 101,208 units of the 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. The affected product codes are L084A13A, L095F13A, L027H13A, and L102K13A. The product was distributed nationwide.

Consumers should check their bottles for the affected codes and stop using the product if it matches the recalled description. The agency classification for this recall is Class II.

The recalled product

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
Manufacturer
Qualitest Pharmaceuticals
Category
Drug — OTC Pain Reliever
Hazard
Affected units
101,208

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 (4)

  • Codes: L084A13A
  • L095F13A
  • L027H13A
  • L102K13A

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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