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Class II · ModerateRecall completed

CORRECTDOSE Children's PAIN RELIEF & Fever Reducer

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

Does this affect you?
Check your lot numberLot # 20096A, EXP Oct. 2022
Where it was soldDistributed Nationwide in the USA
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: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

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

Distributed by / forCorrect Dose Inc, Braintree MA 02184
NDC62320-311-05
Show the full FDA record
Full product labelCORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0
Recalling firmPlastikon Healthcare LLC
DistributionDistributed Nationwide in the USA
Quantity1,464 ampoules
Recall initiated2022-06-07
Report date2022-09-14
Recall completed2025-06-25
Recall numberD-1493-2022
ClassificationClass II
FDA statusTerminated
Origin on fileLawrence KS United States

Related

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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.