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Class III: unlikely to cause harmTerminated

Bayer Chewable Low Dose Aspirin 81 mg Orange Recall

Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distri…

Bayer HealthCare Pharmaceuticals, Inc. · Whippany, NJ

Risk level
Class III
Reported by FDA
Jan 3, 2018
Recall ID
D-0135-2018
Check your lot numberHow we source this data

Summary

Bayer HealthCare Pharmaceuticals recalled Bayer Chewable Low Dose Aspirin 81 mg Orange starting Nov 10, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0135-2018 on Jan 3, 2018. Reason: Failed Stability Specifications. Status: Terminated.

Why it was recalled

Failed Stability Specifications

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

Lot numbers, UPCs & expiration codes

Lot # NAA3T0X; Exp. 07/18

Where it was sold

Natonwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0135-2018
Classification
Class III
Status
Terminated
Recall initiated
Nov 10, 2017
FDA report date
Jan 3, 2018
Quantity
104,128 HDPE bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Bayer HealthCare Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0135-2018, exactly as published.

Show all FDA fields
City
Whippany
State
NJ
Status
Terminated
Country
United States
Event ID
78505
Address
100 Bayer Blvd
Code information
Lot # NAA3T0X; Exp. 07/18
Postal code
07981-1544
Report date
Jan 3, 2018
Product type
Drugs
Recall number
D-0135-2018
Classification
Class III
Recalling firm
Bayer HealthCare Pharmaceuticals, Inc.
Product quantity
104,128 HDPE bottles
Termination date
Apr 3, 2020
Reason for recall
Failed Stability Specifications
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Natonwide
Recall initiation date
Nov 10, 2017
Initial firm notification
Letter
Center classification date
Dec 28, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0135-2018, published Jan 3, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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