Class II · Moderate risk Terminated
Econazole Nitrate Cream
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Econazole Nitrate Cream
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
What was recalled
Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pharmaceuticals, Inc., The Physican's Solution, Mfg: Teligent Pharma, Inc., NDC 68788-7406-03
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- NDC code
- 68788-7406-03
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0771-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Econazole recalls
See all
Class II · Moderate risk Terminated
Econazole Nitrate Cream 1%
Reason Correct Labeled Product Mispack
Class II · Moderate risk Terminated
Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube
Reason Lack of Processing Control
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