FDA Recall D-0697-2018
Bayer HealthCare Pharmaceuticals, Inc. · Whippany, NJ
Class I — life-threatening Terminated 670 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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.
Reason for recall
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.
Recall record
- Recall number
D-0697-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA
- Recall initiated
- 2018-03-15
- Classified by FDA Center
- 2018-04-24
- FDA published
- 2018-05-02
- Terminated
- 2020-01-14
- Recalling firm
- Bayer HealthCare Pharmaceuticals, Inc.
- Firm location
- Whippany, NJ