Drug product
ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30.
D-0662-2016
Product summary
- Event
- Event 72323
- Status
- Terminated
- Classification
- Class I
- Quantity
- 7,372 HDPE Bottles
- Official record key
drug-enforcement:D-0662-2016
Official wording
Reason: Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Code information: lot # 45810; Exp. 05/18
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
mislabeled