Acetaminophen Tablets Recalled Due to Foreign Tablet Contamination
H J Harkins Company Inc is recalling Acetaminophen 500 mg tablets because a foreign Women's Prenatal tablet was found in the product.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (foreign object contamination in medication) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
H J Harkins Company Inc dba Pharma Pac is recalling Acetaminophen 500 mg tablets packaged in 30, 42, 45, and 50-count bottles. The recall is due to a complaint involving one Women's Prenatal dietary supplement tablet found commingled in a bottle of Extra Strength Acetaminophen 500 mg contents.
The affected product includes Lot # AE00M with an expiration date of 08/2021. The total quantity involved is 11,973 tablets. The product was distributed nationwide within the United States.
Consumers should check their medication for the specific NDC codes and lot number listed in the recall notice. If the product is found, consumers should stop using it and contact the recalling firm for instructions on disposal or return.
The recalled product
- Product
- Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J. Harkins Co., Inc. Grover Beach, CA 93433
- Manufacturer
- H J Harkins Company Inc dba Pharma Pac
- Category
- Drug — Tablets
- Hazard
- Affected units
- 11,973
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 #: AE00M
- exp. date 08/2021
Distribution
Distributed nationwide across the United States.
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