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Home Children's medicine Unipharma, Llc. — DrKids Children's Pain &…

Food & drug recall · FDAMay 2, 2019Serious

Unipharma, Llc. — 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

Check whether yours is affected, then follow the instructions below.

What’s wrong

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

The Recall Registry rates this seriousFDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have, and follow the FDA recall notice for what to do with the affected product. If you use it daily, or it is for a child, your pharmacist can tell you whether it matters and what to use instead.

Who to contact: Recalling firm: Unipharma, Llc.

The 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

Details

Units affected
280 cartons
Recall date
May 2, 2019
Brand
Unipharma, Llc.
Model, lot or SKU numbers
Lots: 80061 Exp. 11/30/20
Barcodes (UPC)
370302223019
Where it was distributed

Nationwide and Venezuela

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: Unipharma, Llc. — 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

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Children's medicine

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