Medications & Supplements/Prescription Drugs

H J Harkins Company Inc dba Pharma Pac: Acetaminophen and Codeine Phosphate Tablets Recalled for cGMP Deviations

Agency Publication Date: April 16, 2020

Summary

H J Harkins Company Inc dba Pharma Pac is recalling 9,000 tablets of Acetaminophen and Codeine Phosphate (300/30 mg), a prescription pain medication. The recall was initiated due to deviations from Current Good Manufacturing Practice (cGMP) requirements, which are the federal standards for ensuring drug quality and safety. The affected tablets were distributed in California and Arizona and were repackaged into various bottle sizes ranging from 10 to 60 counts.

Risk

Failure to follow good manufacturing practices can result in medications that do not meet quality standards, potentially affecting the drug's safety, identity, strength, or purity.

What You Should Do

Check your prescription bottle for 'Acetaminophen and Codeine Phosphate 300/30 mg' repackaged by H.J. Harkins Co., Inc.
Identify if your medication is part of this recall by looking for Lot # ATP12ZT with an expiration date of 05/21 on the label.
Verify if the National Drug Code (NDC) on your bottle matches any of the following: 52959-0003-10, 52959-0003-12, 52959-0003-14, 52959-0003-15, 52959-0003-16, 52959-0003-20, 52959-0003-30, or 52959-0003-60.
Contact your healthcare provider or pharmacist immediately to discuss using this medication and to obtain a replacement or alternative treatment.
Return any unused product to the pharmacy or place of purchase for a refund and contact H J Harkins Company Inc (Pharma Pac) for further instructions.
Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

Full Refund

Pharmaceutical recall baseline remedy.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Acetaminophen and Codeine Phosphate 300/30 mg (10-count bottle)

Model:

NDC 52959-0003-10

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Product: Acetaminophen and Codeine Phosphate 300/30 mg (12-count bottle)

Model:

NDC 52959-0003-12

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Product: Acetaminophen and Codeine Phosphate 300/30 mg (14-count bottle)

Model:

NDC 52959-0003-14

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Product: Acetaminophen and Codeine Phosphate 300/30 mg (15-count bottle)

Model:

NDC 52959-0003-15

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Product: Acetaminophen and Codeine Phosphate 300/30 mg (16-count bottle)

Model:

NDC 52959-0003-16

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Product: Acetaminophen and Codeine Phosphate 300/30 mg (20-count bottle)

Model:

NDC 52959-0003-20

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Product: Acetaminophen and Codeine Phosphate 300/30 mg (30-count bottle)

Model:

NDC 52959-0003-30

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Product: Acetaminophen and Codeine Phosphate 300/30 mg (60-count bottle)

Model:

NDC 52959-0003-60

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85482

Status: Resolved

Manufacturer: H J Harkins Company Inc dba Pharma Pac

Sold By: pharmacies; healthcare providers

Manufactured In: United States

Units Affected: 9,000 tablets

Distributed To: California, Arizona

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your prescription bottle for 'Acetaminophen and Codeine Phosphate 300/30 mg' repackaged by H.J. Harkins Co., Inc.

Identify if your medication is part of this recall by looking for Lot # ATP12ZT with an expiration date of 05/21 on the label.

Verify if the National Drug Code (NDC) on your bottle matches any of the following: 52959-0003-10, 52959-0003-12, 52959-0003-14, 52959-0003-15, 52959-0003-16, 52959-0003-20, 52959-0003-30, or 52959-0003-60.

Contact your healthcare provider or pharmacist immediately to discuss using this medication and to obtain a replacement or alternative treatment.

Return any unused product to the pharmacy or place of purchase for a refund and contact H J Harkins Company Inc (Pharma Pac) for further instructions.

Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Affected Products

Product: Acetaminophen and Codeine Phosphate 300/30 mg (10-count bottle)

Model:

NDC 52959-0003-10

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Product: Acetaminophen and Codeine Phosphate 300/30 mg (12-count bottle)

Model:

NDC 52959-0003-12

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Product: Acetaminophen and Codeine Phosphate 300/30 mg (14-count bottle)

Model:

NDC 52959-0003-14

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Product: Acetaminophen and Codeine Phosphate 300/30 mg (15-count bottle)

Model:

NDC 52959-0003-15

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Product: Acetaminophen and Codeine Phosphate 300/30 mg (16-count bottle)

Model:

NDC 52959-0003-16

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Product: Acetaminophen and Codeine Phosphate 300/30 mg (20-count bottle)

Model:

NDC 52959-0003-20

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Product: Acetaminophen and Codeine Phosphate 300/30 mg (30-count bottle)

Model:

NDC 52959-0003-30

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21

Product: Acetaminophen and Codeine Phosphate 300/30 mg (60-count bottle)

Model:

NDC 52959-0003-60

Lot Numbers:

ATP12ZT (Exp. 05/21)

Date Ranges: 05/21