Recalls / Class II
Class IID-1005-2020
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
- Affected lot / code info
- Lot #: AE00M, exp. date 08/2021
Why it 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
Recalling firm
- Firm
- H J Harkins Company Inc dba Pharma Pac
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1400 W Grand Ave Ste F, Grover Beach, California 93433-4221
Distribution
- Quantity
- 11,973 tablets
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-03-06
- FDA classified
- 2020-03-12
- Posted by FDA
- 2020-03-18
- Terminated
- 2024-01-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1005-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.