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Recall Observatory FDA recall evidence

Drug product

All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall.

D-0697-2018

March 15, 2018

Class I

Product summary

Firm
Bayer HealthCare Pharmaceuticals, Inc.
Event
Event 79555
Status
Terminated
Classification
Class I
Quantity
188,631 units
Official record key
drug-enforcement:D-0697-2018

Official wording

Reason: Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.

Code information: The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up