Recalls / Class I

Class ID-0697-2018

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

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.

Affected lot / code info: 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

Why it was recalled

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.

Recalling firm

Firm: Bayer HealthCare Pharmaceuticals, Inc.
Notification channel: Press Release
Type: Voluntary: Firm initiated
Address: 100 Bayer Blvd, N/A, Whippany, New Jersey 07981-1544

Distribution

Quantity: 188,631 units
Distribution pattern: Nationwide in the USA

Timeline

Recall initiated: 2018-03-15
FDA classified: 2018-04-24
Posted by FDA: 2018-05-02
Terminated: 2020-01-14
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0697-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.