FDA recall record

H J Harkins Company Inc dba Pharma Pac Acetaminophen 500 mg tablet recall — FDA D-1005-2020

Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength…

Class IIclassification
D-1005-2020official record ID
Mar 18, 2020report date

Recall record at a glance

Official recordD-1005-2020
CategoryDrug Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmH J Harkins Company Inc dba Pharma Pac
Report dateMar 18, 2020
Recall initiation dateMar 6, 2020
Quantity11,973 tablets
LocationGrover Beach, CA, United States

Official product description

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

Why the product was recalled

Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle

Distribution information

Nationwide within the United States

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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