FDAFDA · Food and drugs·Recall number D-0683-2022
Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11.
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: 15288, Exp. 3/31/2022; 16065, Exp. 10/31/2022; 16430, 16431, Exp. 2/28/2023; 16675, Exp. 3/31/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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