Recalls / Class III
Class IIID-0135-2018
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
- Affected lot / code info
- Lot # NAA3T0X; Exp. 07/18
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- Bayer HealthCare Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Bayer Blvd, N/A, Whippany, New Jersey 07981-1544
Distribution
- Quantity
- 104,128 HDPE bottles
- Distribution pattern
- Natonwide
Timeline
- Recall initiated
- 2017-11-10
- FDA classified
- 2017-12-28
- Posted by FDA
- 2018-01-03
- Terminated
- 2020-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0135-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.