Product Safety Recalls

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Recall D-1353-2022

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

Recall D-1353-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1353-2022
Event ID90682
DistributionProduct was distributed to 6 distributors/wholesalers who may have further distributed the product.
Quantity30,325 bottles
Recall ReasonFailed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Drug ClassificationClass III
Drug Code Info20220824
Recall Initiation Date20220804
Report Date20220824
Classification Date20220817
Address373 Us Highway 46 Ste 117
Fairfield, NJ 07004-2456
United States
Recalling FirmAkron Pharma, Inc.
Initial Notification Letter
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