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
D-0135-2018
Product summary
- Event
- Event 78505
- Status
- Terminated
- Classification
- Class III
- Quantity
- 104,128 HDPE bottles
- Official record key
drug-enforcement:D-0135-2018
Official wording
Reason: Failed Stability Specifications
Code information: Lot # NAA3T0X; Exp. 07/18
Distribution pattern: Natonwide
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications