FDAFDA · Food and drugs·Recall number D-0682-2022
Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
Published March 30, 2022 · Recall initiated: March 15, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teligent Pharma, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Batch: a) 16410, 16438, Exp. 1/31/2023; 16882, Exp. 4/30/2023; b) 15349, Exp. 2/28/2022; 16410, 16438, Exp. 1/31/2023; 16882, Exp. 4/30/2023; c) 16410, 16438, Exp. 1/31/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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