FDA Recalls Acetaminophen and Codeine Tablets Due to Manufacturing Deviations
H J Harkins Company is recalling 9,000 tablets of Acetaminophen and Codeine Phosphate 300/30 mg due to cGMP deviations. The product was distributed in California and Arizona.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences. The source cites cGMP deviations without reporting specific illnesses or injuries, aligning with the Moderate severity criteria for voluntary precautionary recalls.
Plain-English summary
H J Harkins Company Inc dba Pharma Pac is voluntarily recalling 9,000 tablets of Acetaminophen and Codeine Phosphate 300/30 mg. The recall was initiated on April 15, 2020, and is classified as Class II by the FDA. The specific reason for the recall is cited as cGMP (Current Good Manufacturing Practice) deviations.
The affected product is Lot # ATP12ZT with an expiration date of 05/21. It is packaged in various bottle sizes, including 10, 12, 14, 15, 16, 20, 30, and 60-count bottles. The product was manufactured by Aurobindo and repackaged by H.J. Harkins Co., Inc. in Grover Beach, California.
The product was distributed in California and Arizona. Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Acetaminophen 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…
- Manufacturer
- H J Harkins Company Inc dba Pharma Pac
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 9,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # ATP12ZT
- Exp. 05/21
Distribution
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