TRIAMCINOLONE ACETONIDE Recall D-0697-2022
Description: 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.
TRIAMCINOLONE ACETONIDE Recall D-0697-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0697-2022 |
Event ID | 89798 |
Brand | TRIAMCINOLONE ACETONIDE |
Generic Name | TRIAMCINOLONE ACETONIDE |
Manufacturer | TRIAMCINOLONE ACETONIDE |
Original Package? | 1 |
Active Substance | TRIAMCINOLONE ACETONIDE |
Drug Route | TOPICAL |
Distribution | Nationwide in the USA and Puerto Rico |
Quantity | 721,225 tubes; 90,893 jars |
Recall Reason | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. |
Drug Classification | Class II |
Drug Code Info | 20220330 |
Product NDC | 52565-056 |
Product NUI | N0000175576 N0000175450 |
Drug UPC | 0352565056153 0352565056269 |
Pharma Class (EPC) | Corticosteroid [EPC] |
Recall Initiation Date | 20220315 |
Report Date | 20220330 |
Classification Date | 20220321 |
Address | 105 Lincoln Avenue Buena, NJ 08310 United States |
Recalling Firm | Teligent Pharma, Inc. |
Initial Notification | Letter |
Unique Ingredient Identifier | F446C597KA |
Drug Application Number | ANDA208848 |
Structured Product Labeling (SPL ID) | 68429a04-764e-44ec-8359-0050d9dd5544 |
Structured Product Labeling (SPL Set ID) | f660c29d-1a39-32e8-567e-ed6dd96fde8d |
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