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
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
Lot numbers, UPCs & expiration codes
Lot #: AE00M, exp. date 08/2021
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1005-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 6, 2020
- FDA report date
- Mar 18, 2020
- Quantity
- 11,973 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
Original FDA data
Every field from FDA enforcement report D-1005-2020, exactly as published.
Show all FDA fields
- City
- Grover Beach
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 85158
- Address
- 1400 W Grand Ave Ste F
- Code information
- Lot #: AE00M, exp. date 08/2021
- Postal code
- 93433-4221
- Report date
- Mar 18, 2020
- Product type
- Drugs
- Recall number
- D-1005-2020
- Classification
- Class II
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
- Product quantity
- 11,973 tablets
- Termination date
- Jan 17, 2024
- Reason for recall
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Mar 6, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2020