FDAFDA · Food and drugs·Recall number D-1353-2022
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
Published August 24, 2022 · Recall initiated: August 4, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akron Pharma, Inc.
- Distributor
- Product was distributed to 6 distributors/wholesalers who may have further distributed the product.
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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