Reported Nov 24, 2021 · Terminated
LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC…
Bayer Healthcare Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bayer Healthcare Pharmaceuticals Inc. · 100 Bayer Blvd · Whippany, NJ · 07981-1544
Is this the product you have?
- LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3
- Dist byBayer Healthcare LLC, Whippany, NJ 07981, Product of Spain
- Lot codes and dates
21 of 21 products
Products covered by this recall # Product as published 1 Lot # (a) CV017D9, EXP 10/31/2021 2 CV01940, EXP 11/30/2021 3 CV01CD9, EXP 4/30/2022 4 CV01D9T, CV01DZ3, EXP 6/30/2022 5 CV01EPP, EXP 7/31/2022 6 TN000TT, EXP 10/31/2022 7 TN003CG, EXP 1/31/2023 8 TN003CH, TN00407, EXP 3/31/2023 9 TN0041V, EXP 6/30/2023 10 TN0056W, EXP 7/31/2022 11 TN005P4, EXP 8/31/2022 12 TN006MJ, EXP 9/30/2022 13 (b) CV01940, CV01940A, EXP 11/30/2021 14 CV01AP2, EXP 02/28/2022 15 CV01D9T, CV01D9TA, CV01DZ3, EXP 06/30/2022 16 CV01EPP, EXP 07/31/2022 17 TN005P4, EXP 08/31/2022 18 TN000TT, TN000TTA, EXP 10/31/2022 19 TN003CG, EXP 01/31/2023 20 TN003CH, TN003CHA, TN00407, TN006TD, TN006TDB, TN00407A, EXP 03/31/2023 - Amount recalled
- 3,816,468 cans
This recall covers 19 products
The agency filed one notice per product. You are reading one of them; the other 18 are below.
6 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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