FlaggedRx← Medication recall checkHome
Class II · ModerateRecall completed

Acetaminophen and Codeine Phosphate 300/30 mg tablet

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

Does this affect you?
Check your lot numberLot # ATP12ZT, Exp. 05/21
Where it was soldProduct was distributed in CA and AZ.
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 / forH J Harkins Company Inc dba Pharma Pac
NDC52959-0003-10
Show the full FDA record
Full product labelAcetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433
Recalling firmH J Harkins Company Inc dba Pharma Pac
DistributionProduct was distributed in CA and AZ.
Quantity9,000 tablets
Recall initiated2020-04-15
Report date2020-04-22
Recall completed2024-02-14
Recall numberD-1246-2020
ClassificationClass II
FDA statusTerminated
Origin on fileGrover Beach CA United States

Related

Acetaminophen recallsRecent drug recallsCheck another medication

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.