FDA recall D-1353-2022

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

Reason for recall

Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

Distribution

Product was distributed to 6 distributors/wholesalers who may have further distributed the product.

Key facts

Status

Terminated

Initiation date

2022-08-04

Report date

2022-08-24

Termination date

2023-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fairfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1353-2022