TRETINOIN Recall D-1156-2022
Description: Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
TRETINOIN Recall D-1156-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1156-2022 |
| Event ID | 90430 |
| Brand | TRETINOIN |
| Generic Name | TRETINOIN |
| Manufacturer | TRETINOIN |
| Original Package? | 1 |
| Active Substance | TRETINOIN |
| Drug Route | ORAL |
| Distribution | Nationwide in the U.S. |
| Quantity | 4941 bottles |
| Recall Reason | Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution. |
| Drug Classification | Class II |
| Drug Code Info | 20220629 |
| Product NDC | 0555-0808 |
| Product NUI | N0000175607 M0018962 |
| Drug UPC | 0305550808022 |
| Pharma Class (EPC) | Retinoid [EPC] |
| Pharma Class (CS) | Retinoids [CS] |
| Recall Initiation Date | 20220614 |
| Report Date | 20220629 |
| Classification Date | 20220623 |
| Address | 400 Interpace Pkwy Bldg A Parsippany, NJ 07054-1120 United States |
| Recalling Firm | Teva Pharmaceuticals USA Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 5688UTC01R |
| Drug Application Number | ANDA077684 |
| Structured Product Labeling (SPL ID) | 4d40143c-dd75-4305-b00e-737e41e5431a |
| Structured Product Labeling (SPL Set ID) | 0f81f505-a962-414e-8612-c3ef3b159e9a |
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