The Recall Desk
ModerateFDA (Drugs)·D-1299-2019·Announced 2019-05-22

DrKids Children's Pain & Fever Oral Solution Recalled for B. cepacia Risk

Unipharma, LLC is recalling 280 cartons of DrKids Children's Pain & Fever Oral Solution due to potential contamination with B. cepacia bacteria.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is a voluntary precautionary measure due to potential contamination with B. cepacia, which fits the rubric for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Unipharma, LLC is voluntarily recalling 280 cartons of DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured Single-Use Vials, Cherry Flavor. The recall is a precautionary measure taken due to potential risk of product contamination with the bacteria B. cepacia.

The affected product is identified by Lot 80061 with an expiration date of 11/30/20. The product was distributed nationwide and in Venezuela.

Consumers who have purchased this product should stop using it and contact the manufacturer for further instructions.

The recalled product

Product
DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL), Cherry Flavor, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-011-20, UPC 370302223019
Manufacturer
Unipharma, Llc.
Affected units
280

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 (1)

  • Lots: 80061 Exp. 11/30/20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Unipharma, Llc. 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 11 products in this recall →