Bayer Healthcare Pharmaceuticals Inc.: Drug Recall
Recall #D-0245-2022 · 10/01/2021
Class II: Risk
Recall Details
- Recall Number
- D-0245-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Bayer Healthcare Pharmaceuticals Inc.
- Status
- Terminated
- Date Initiated
- 10/01/2021
- Location
- Whippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,841,012 cans
Reason for Recall
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Product Description
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
Distribution Pattern
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Other Recalls by Bayer Healthcare Pharmaceuticals Inc.
- Class I: Dangerous 11/06/2023
- Class I: Dangerous 10/01/2021
- Class I: Dangerous 10/01/2021
- Class II: Risk 10/01/2021
- Class I: Dangerous 10/01/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.