Drug product
Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India
D-0627-2024
Product summary
- Event
- Event 94981
- Status
- Terminated
- Classification
- Class III
- Quantity
- 21,192 Bottles
- Official record key
drug-enforcement:D-0627-2024
Official wording
Reason: Label mix-up: Carton incorrectly labeled.
Code information: Lot #: 31670346AA, Exp 12/31/2026
Distribution pattern: Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.
Derived failure modes
-
Labeling or packaging
Label mix-up