Recalls / Class III
Class IIID-1353-2022
Product
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
- Affected lot / code info
- 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
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
- 30,325 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-1353-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.