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Class II · ModerateRecall completed

Children's Acetaminophen Liquid

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 17E035, Exp. 05/2019
Where it was soldProduct was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byBio-Pharm, Inc., Levittown PA 19057, Assured
Distributed by / forTorrent Pharma Inc
NDC59741-101-06
Show the full FDA record
Full product labelChildren's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free, Cherry Flavor, 4 FL. oz. (118 mL) bottle, NDC: 59741-101-06, Manufactured by Bio-Pharm, Inc., Levittown PA 19057, Assured.
Recalling firmTorrent Pharma Inc
DistributionProduct was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Quantity58,272 bottles
Recall initiated2019-05-21
Report date2019-06-19
Recall completed2020-10-06
Recall numberD-1346-2019
ClassificationClass II
FDA statusTerminated
Origin on fileLevittown PA United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.