D-0663-2016 Class I Terminated
FDA drug recall D-0663-2016 was initiated by Medline Industries Inc on Sep 25, 2015 and is designated Class I. Reason for recall: Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets. The recall status is terminated (terminated Jun 29, 2016).
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 24, 2016
- Initiation Date
- Sep 25, 2015
- Termination Date
- Jun 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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.
Distribution Pattern
Nationwide
Code Information
lot # 45810; Exp. 05/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0663-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026