Why it was recalled
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Product description
Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
Lot numbers, UPCs & expiration codes
Lot#: AXA2014, Exp Feb-23; AXB2001, Exp Nov-22; AXB2002, AXB2003, AXB2004, AXB2005, AXB2006, AXB2007, AXB2008, AXB2009, AXB2010, AXB2011, Exp Dec-22; AXB2012, AXB2013, AXB2014, AXB2015, AXB2016, AXB2017, AXB2018, AXB2019, AXB2020, AXB2021, AXB2022, AXB2023, AXB2024, AXB2025, AXB2026, AXB2027, Exp Feb-23
Where it was sold
Product was distributed to 6 distributors/wholesalers who may have further distributed the product.
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-1353-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 4, 2022
- FDA report date
- Aug 24, 2022
- Quantity
- 30,325 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akron Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-1353-2022, exactly as published.
Show all FDA fields
- City
- Fairfield
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90682
- Address
- 373 Us Highway 46 Ste 117
- Code information
- Lot#: AXA2014, Exp Feb-23; AXB2001, Exp Nov-22; AXB2002, AXB2003, AXB2004, AXB2005, AXB2006, AXB2007, AXB2008, AXB2009, AXB2010, AXB2011, Exp Dec-22; AXB2012, AXB2013, AXB2014, AXB2015, AXB2016, AXB2017, AXB2018, AXB2019, AXB2020, AXB2021, AXB2022, AXB2023, AXB2024, AXB2025, AXB2026, AXB2027, Exp Feb-23
- Postal code
- 07004-2456
- Report date
- Aug 24, 2022
- Product type
- Drugs
- Recall number
- D-1353-2022
- Classification
- Class III
- Recalling firm
- Akron Pharma, Inc.
- Product quantity
- 30,325 bottles
- Termination date
- Dec 4, 2023
- Reason for recall
- Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
- Distribution pattern
- Product was distributed to 6 distributors/wholesalers who may have further distributed the product.
- Recall initiation date
- Aug 4, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 17, 2022