FDA Drug Recalls

Recalls / Class III

Class IIID-0925-2017

Product

Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL) bottles connected by one paper sleeve, TOTAL 24 FL OZ (1.5 pt)(710 mL), OTC, Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015

Affected lot / code info
Lot #: 6MV0944, Exp 10/18

Why it was recalled

Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid.

Recalling firm

Firm
L. Perrigo Company
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
515 Eastern Ave, N/A, Allegan, Michigan 49010-9070

Distribution

Quantity
1,998 combo packs
Distribution pattern
IL

Timeline

Recall initiated
2017-06-05
FDA classified
2017-06-28
Posted by FDA
2017-07-05
Terminated
2017-12-07
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0925-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls