Reported Aug 24, 2022 · Terminated
Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle…
Akron Pharma, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akron Pharma, Inc. · 373 Us Highway 46 Ste 117 · Fairfield, NJ · 07004-2456
Is this the product you have?
- 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 forAkorn Pharma, Inc., Fairfield, NJ
- Lot codes and dates
Lot#: AXA2014Exp Feb-23AXB2001Exp Nov-22AXB2002AXB2003AXB2004AXB2005AXB2006AXB2007AXB2008AXB2009AXB2010AXB2011Exp Dec-22AXB2012AXB2013AXB2014AXB2015AXB2016AXB2017AXB2018AXB2019AXB2020AXB2021AXB2022AXB2023AXB2024AXB2025AXB2026AXB2027Exp Feb-23
- Amount recalled
- 30,325 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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