FDAFDA · Food and drugs·Recall number D-0671-2022
Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 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) 15377, Exp. 3/31/2022; 15927, Exp. 9/30/2022; 16130, Exp. 11/30/2022; b) 15117, Exp. 2/28/2022; 16028, Exp. 9/30/2022; 16945, Exp. 5/31/2023; c) 15377, Exp. 3/31/2022; 15927, Exp. 9/30/2022; 16683, Exp. 5/31/2022; d) 15116, Exp. 2/28/2022; 15117, Exp. 2/28/2022; 16130, Exp. 11/30/2022; 16228, Exp. 11/30/2022; 16348, Exp. 1/31/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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