FDA recall D-0662-2016

Product

ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30.

Reason for recall

Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-09-25

Report date

2016-02-24

Termination date

2016-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mundelein, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0662-2016