NYSTATIN Recall D-0695-2022
Description: 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.
NYSTATIN Recall D-0695-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0695-2022 |
| Event ID | 89798 |
| Brand | NYSTATIN AND TRIAMCINOLONE ACETONIDE |
| Generic Name | NYSTATIN AND TRIAMCINOLONE ACETONIDE |
| Manufacturer | NYSTATIN AND TRIAMCINOLONE ACETONIDE |
| Original Package? | 1 |
| Active Substance | NYSTATIN TRIAMCINOLONE ACETONIDE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 217,184 tubes |
| 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 | 52565-042 |
| Product NUI | N0000175498 M0017172 N0000175576 |
| Pharma Class (EPC) | Polyene Antifungal [EPC] |
| Pharma Class (CS) | Polyenes [CS] |
| 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 | BDF1O1C72E F446C597KA |
| Drug Application Number | ANDA208287 |
| Structured Product Labeling (SPL ID) | 1090fb75-b1de-4939-8695-2870797e40bc |
| Structured Product Labeling (SPL Set ID) | 373276df-6a72-44cb-82a2-4098a16d86c7 |
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