D-0319-2015 Class II Terminated
FDA drug recall D-0319-2015 was initiated by LNK International, Inc. on Jul 18, 2012 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Dec 23, 2014). Affected quantity: 9,379 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 31, 2014
- Initiation Date
- Jul 18, 2012
- Termination Date
- Dec 23, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,379 bottles
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
Lot Number P78221, expiration date 05/14; Lot Number P78222, expiration date 05/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0319-2015
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026