FDA Recall D-0663-2016
Medline Industries Inc · Mundelein, IL
Class I — life-threatening Terminated 278 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30.
Reason for recall
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Recall record
- Recall number
D-0663-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2015-09-25
- Classified by FDA Center
- 2016-02-12
- FDA published
- 2016-02-24
- Terminated
- 2016-06-29
- Recalling firm
- Medline Industries Inc
- Firm location
- Mundelein, IL