November 2017 FDA Recall Drug by Bayer Healthcare Pharmaceuticals, Inc.
D-0135-2018 - Failed Stability Specifications

This Class III drug recall was voluntarily initiated by Bayer Healthcare Pharmaceuticals, Inc. on November 10, 2017 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed in Natonwide and the recall is currently terminated.

Recall Number: D-0135-2018

Reason for Recall
Failed Stability Specifications
Initiated
11-10-2017
Reported
01-03-2018
Quantity
104,128 HDPE bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78505
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bayer HealthCare Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Natonwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-03-2020
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# NAA3T0X; Exp. 07/18