FDAFDA · Food and drugs·Recall number D-0695-2022
Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30; c) 60 grams tubes, NDC 52565-042-60, 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) 15125, Exp. 2/28/2022; 15385, Exp. 3/31/2022; 15613, Exp. 5/31/2022; 16027, Exp. 9/30/2022; 16204, Exp. 11/30/2022; 16376, Exp. 1/31/2023; 16707, Exp. 3/31/2023; b) 15385, Exp. 3/31/2022; 15752, Exp. 6/30/2022; 15346, Exp. 9/30/2022; 16188, Exp. 11/30/2022; 16567, Exp. 2/28/2023; 16730, Exp. 4/30/2023; c)15752, Exp. 6/30/2022; 16188, Exp. 11/30/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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