TRIAMCINOLONE ACETONIDE Recall D-0699-2022
Description: Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 52565-014-80; c) 1 lb (454 g) jars, NDC 52565-014-26; Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
TRIAMCINOLONE ACETONIDE Recall D-0699-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0699-2022 |
| 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 | 482,003 tubes; 45,583 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 | 52565-014 59088-770 |
| Product NUI | N0000175576 N0000175450 |
| 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 | ANDA205373 |
| Structured Product Labeling (SPL ID) | 48fc2abe-dc67-4be0-97df-a2ca347c1efb |
| Structured Product Labeling (SPL Set ID) | c25f35ab-c04c-496d-803f-2e497292faf8 |
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