Recalls / Class II
Class IID-0319-2015
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
- Affected lot / code info
- Lot Number P78221, expiration date 05/14; Lot Number P78222, expiration date 05/14
Why it was recalled
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.
Recalling firm
- Firm
- LNK International, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 40 & 60 Arkay Drive, Hauppauge, New York 11788-3708
Distribution
- Quantity
- 9,379 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-07-18
- FDA classified
- 2014-12-23
- Posted by FDA
- 2014-12-31
- Terminated
- 2014-12-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0319-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.