FDA recall D-0135-2018
Bayer HealthCare Pharmaceuticals, Inc. · Class III · drug
Product
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577
Reason for recall
Failed Stability Specifications
Distribution
Natonwide
Key facts
- Status
- Terminated
- Initiation date
- 2017-11-10
- Report date
- 2018-01-03
- Termination date
- 2020-04-03
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Whippany, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0135-2018