FDAFDA · Food and drugs·Recall number D-0697-2022
Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-26; Rx Only, 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) 15123, Exp. 2/28/2022; 15875, Exp. 8/31/2022; 16115, Exp. 10/31/2022; b) 15123, 15201, Exp. 2/28/2022; 15477, Exp. 4/30/2022; 15897, Exp. 8/31/2022; 16090, Exp. 10/31/2022; 16374, Exp. 1/31/2023; 16676, Exp. 3/31/2023; 17109, Exp. 7/31/2023; c) 15241, Exp. 2/28/2022; 16610, Exp. 3/31/2023; d) 15121, 15127, 15191, 15201, 15278, Exp. 2/28/2022;15386, 15567, Exp. 4/30/2022; 15875, Exp. 8/31/2022; 16050, 16051, 16115, Exp. 10/31/2022; 16165, 16201, Exp. 11/30/2022; 16609, 16610, 16624, Exp. 3/31/2023; 16700, Exp. 4/30/2023; 16732, Exp. 5/31/2023; 17081, 17108, Exp. 7/31/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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