Recall Enforment Report D-1353-2022

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Akron Pharma, Inc., originally initiated on 08-04-2022 for 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 The product was recalled due to failed tablet/capsule specifications: imprint "ap 325" is missing from the tablet.. 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.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-1353-2022	08-04-2022	08-24-2022	Class III	30,325 bottles	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	Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.	Terminated
D-1352-2022	08-04-2022	08-24-2022	Class III	301,382 bottles	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	Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.	Terminated

Field Name	Field Value
Event ID	90682 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1353-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product was distributed to 6 distributors/wholesalers who may have further distributed the product. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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
Reason For Recall	Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	30,325 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-24-2022
Recall Initiation Date	08-04-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	12-04-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Akron Pharma, Inc.
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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	90682 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1352-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product was distributed to 6 distributors/wholesalers who may have further distributed the product. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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
Reason For Recall	Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	301,382 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-24-2022
Recall Initiation Date	08-04-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	12-04-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Akron Pharma, Inc.
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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.