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Class II · ModerateRecall completed

4-Component Cold Tabs (Acetaminophen 325 mg

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

Does this affect you?
Check your lot numberProduct Code: C107L Bulk Lots: 18G085, 19B061, 19F066, 19J068 Product Code: C107LB Bulk Lots: 18J051, 18M079, 18M080, 19B017, 19B018, 19C001, 19C081, 19D056, 19D057 Product C107LA: Bulk lots: 19F067
Where it was soldBulk product was distributed to 3 distributors who may have distributed finished product.
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

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 / forULTRAtab Laboratories, Inc.
NDC62959-107-00
Show the full FDA record
Full product label4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00
Recalling firmULTRAtab Laboratories, Inc.
DistributionBulk product was distributed to 3 distributors who may have distributed finished product.
Quantity19,103,287 tablets
Recall initiated2022-01-26
Report date2022-02-16
Recall completed2025-01-07
Recall numberD-0524-2022
ClassificationClass II
FDA statusTerminated
Origin on fileHighland NY 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.