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.
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
Lot numbers, UPCs & expiration codes
Lot Number P78221, expiration date 05/14; Lot Number P78222, expiration date 05/14
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0319-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 18, 2012
- FDA report date
- Dec 31, 2014
- Quantity
- 9,379 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LNK International, Inc.
Original FDA data
Every field from FDA enforcement report D-0319-2015, exactly as published.
Show all FDA fields
- City
- Hauppauge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 62613
- Address
- 40 & 60 Arkay Drive
- Code information
- Lot Number P78221, expiration date 05/14; Lot Number P78222, expiration date 05/14
- Postal code
- 11788-3708
- Report date
- Dec 31, 2014
- Product type
- Drugs
- Recall number
- D-0319-2015
- Classification
- Class II
- Recalling firm
- LNK International, Inc.
- Product quantity
- 9,379 bottles
- Termination date
- Dec 23, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 18, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 23, 2014