Drug product
Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine, 100 Coated Caplets, OTC --- Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, Item # 427594, NDC 0363-0428-12, UPC Code 311917134925
D-0319-2015
Product summary
- Event
- Event 62613
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,379 bottles
- Official record key
drug-enforcement:D-0319-2015
Official wording
Reason: Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.
Code information: Lot Number P78221, expiration date 05/14; Lot Number P78222, expiration date 05/14
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.