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Recall Observatory FDA recall evidence

Drug product

Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18

D-0800-2016

February 10, 2016

Class III

Product summary

Firm
Pfizer Inc
Event
Event 73285
Status
Terminated
Classification
Class III
Quantity
63,636 plastic bottles
Official record key
drug-enforcement:D-0800-2016

Official wording

Reason: Labeling: Label Mix-Up

Code information: Lot #: R29364; Exp. 10/17

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up