Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Equate Athlete's Foot (Clotrimazole)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b) NET WT 2 OZ (60g), NDC 49035-812-27. Distributed by: Walmart Inc., Bentonville, AR 72716.
Affected NDCs
49035-0812-01
49035-0812-27
Compare with the code on your package — it is the most precise check available.
Drug: Clotrimazole
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Clotrimazole Athletes Foot Clotrimazole NDC 49035-0812 |
10 mg/g | Cream Topical |
Wal-Mart Stores, Inc. | OTC |
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- NDC code
- 49035-812-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0151-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Clotrimazole recalls
See all
Class II · Moderate risk
Cura Hongos
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Lucky Super Soft
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Globe Clotrimazole Cream USP
cGMP deviations
Class II · Moderate risk
Globe Clotrimazole Cream
cGMP deviations
Other recalls by Taro Pharmaceuticals U.S.A., Inc.
All 2020 recalls
Class III · Low risk
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Class I · High risk
Clobetasol Propionate Ointment USP
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class II · Moderate risk
Nortriptyline HCl Capsules
CGMP deviations.
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