FDA-Drug2022-08-24Class III
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
Akron Pharma, Inc.
Hazard
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Sold states
Product was distributed to 6 distributors/wholesalers who may have further distributed the product.
Affected count
30,325 bottles
Manufactured in
373 Us Highway 46 Ste 117, Fairfield, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1353-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief