FDA recall D-0627-2024

Product

Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India

Reason for recall

Label mix-up: Carton incorrectly labeled.

Distribution

Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.

Key facts

Status

Terminated

Initiation date

2024-07-18

Report date

2024-08-14

Termination date

2026-02-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Manassas, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0627-2024