Why it was recalled
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Product description
Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
Lot numbers, UPCs & expiration codes
Lot #: AXA2001, AXA2002, AXA2003, AXA2004, AXA2005, AXA2006, AXA2007, AXA2008, AXA2009, AXA2010, AXA2011, AXA2012, AXA2013, AXA2014, Exp Feb-23; AKK2021, AKK30421, AKK40421, AKK50421, AKK60421, AKK70421, AKK80421, AKK90421, Exp Mar-24; AKL10421, AKL20421, AKL10521, AKL20521, AKL30521, AKL40521, AKL50521, AKL60521, AKL70521, AKL80521, AKL90521, Exp Apr-24; AKM10521, Exp Apr-24; AKA10621, AKA20621, AKA30621, AKA40621, AKA50621, AKA60621, AKA70621, AKA80621, AKA90621, Exp May-24; AKB10621, Exp May-24
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-1352-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 4, 2022
- FDA report date
- Aug 24, 2022
- Quantity
- 301,382 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akron Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-1352-2022, 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 #: AXA2001, AXA2002, AXA2003, AXA2004, AXA2005, AXA2006, AXA2007, AXA2008, AXA2009, AXA2010, AXA2011, AXA2012, AXA2013, AXA2014, Exp Feb-23; AKK2021, AKK30421, AKK40421, AKK50421, AKK60421, AKK70421, AKK80421, AKK90421, Exp Mar-24; AKL10421, AKL20421, AKL10521, AKL20521, AKL30521, AKL40521, AKL50521, AKL60521, AKL70521, AKL80521, AKL90521, Exp Apr-24; AKM10521, Exp Apr-24; AKA10621, AKA20621, AKA30621, AKA40621, AKA50621, AKA60621, AKA70621, AKA80621, AKA90621, Exp May-24; AKB10621, Exp May-24
- Postal code
- 07004-2456
- Report date
- Aug 24, 2022
- Product type
- Drugs
- Recall number
- D-1352-2022
- Classification
- Class III
- Recalling firm
- Akron Pharma, Inc.
- Product quantity
- 301,382 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 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), 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