Recalls / Class III
Class IIID-1352-2022
Product
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
- Affected lot / code info
- 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
Why it was recalled
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Recalling firm
- Firm
- Akron Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 373 Us Highway 46 Ste 117, Fairfield, New Jersey 07004-2456
Distribution
- Quantity
- 301,382 bottles
- Distribution pattern
- Product was distributed to 6 distributors/wholesalers who may have further distributed the product.
Timeline
- Recall initiated
- 2022-08-04
- FDA classified
- 2022-08-17
- Posted by FDA
- 2022-08-24
- Terminated
- 2023-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1352-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.