Reported Apr 22, 2020 · Terminated

Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in

H J Harkins Company Inc. dba Pharma Pac

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: H J Harkins Company Inc dba Pharma Pac · 1400 W Grand Ave Ste F · Grover Beach, CA · 93433-4221

Is this the product you have?

Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in

8 of 8 products

Products covered by this recall
#Product as published
110-count bottle (NDC 52959-0003-10)
212-count bottle (NDC 52959-0003-12)
314-count bottle (NDC 52959-0003-14)
415-count bottle (NDC 52959-0003-15)
516-count bottle (NDC 52959-0003-16)
620-count bottle (NDC 52959-0003-20)
730-count bottle (NDC 52959-0003-30)
860-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433
Lot codes and dates
    • Lot # ATP12ZT
    • Exp. 05/21
Amount recalled
9,000 tablets

Where it was sold

Why it was recalled

cGMP Deviations

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 14, 2024 · Data as of Sep 19, 7:20 PM UTC

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