D-0135-2018 Class III Terminated
FDA drug recall D-0135-2018 was initiated by Bayer HealthCare Pharmaceuticals, Inc. on November 10, 2017 and is designated Class III. Reason for recall: Failed Stability Specifications The recall status is terminated (terminated April 3, 2020). Affected quantity: 104,128 HDPE bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 3, 2018
- Initiation Date
- November 10, 2017
- Termination Date
- April 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 104,128 HDPE bottles
Product Description
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 Pattern
Natonwide
Code Information
Lot # NAA3T0X; Exp. 07/18