Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: ...
FDA Recall #D-0135-2018 — Class III — November 10, 2017
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
Recalling Firm
Bayer HealthCare Pharmaceuticals, Inc. — Whippany, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
104,128 HDPE bottles
Distribution
Natonwide
Code Information
Lot # NAA3T0X; Exp. 07/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated