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Recall Observatory FDA recall evidence

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

July 18, 2012

Class II

Product summary

Firm
LNK International, Inc.
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

    reason.no_named_rule · v1.0.0

    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.