Multi-event August 2022 FDA Recall Drug by Akron Pharma, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Akron Pharma, Inc. on August 4, 2022 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed in Product was distributed to 6 distributors/wholesalers who may have further distributed the product. and the recall is currently terminated.

Reported Recall Events

D-1353-2022 TERMINATED D-1352-2022 TERMINATED

Recall Number: D-1353-2022

Reason for Recall
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Initiated
08-04-2022
Reported
08-24-2022
Quantity
30,325 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90682
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Akron Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 6 distributors/wholesalers who may have further distributed the product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Recall Number: D-1352-2022

Reason for Recall
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Initiated
08-04-2022
Reported
08-24-2022
Quantity
301,382 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90682
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Akron Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 6 distributors/wholesalers who may have further distributed the product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration 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