Drug 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
D-1005-2020
Product summary
- Event
- Event 85158
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,973 tablets
- Official record key
drug-enforcement:D-1005-2020
Official wording
Reason: 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
Code information: Lot #: AE00M, exp. date 08/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets