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Recall Observatory FDA recall evidence

Drug 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

D-0925-2017

June 05, 2017

Class III

Product summary

Firm
L. Perrigo Company
Event
Event 77450
Status
Terminated
Classification
Class III
Quantity
1,998 combo packs
Official record key
drug-enforcement:D-0925-2017

Official wording

Reason: 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.

Code information: Lot #: 6MV0944, Exp 10/18

Distribution pattern: IL

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up