FDA recall D-0729-2021

Spirit Pharmaceuticals · Class II · drug

Product

Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10

Reason for recall

cGMP deviations: Discolored acetaminophen

Distribution

USA Nationwide

Key facts

Status
Terminated
Initiation date
2021-06-16
Report date
2021-08-25
Termination date
2022-09-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ronkonkoma, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0729-2021