Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose...
Reason for Recall / Hazard
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Product Description & Identification
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,
Affected Products
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,
Additional Source Details
| Field | Value |
|---|---|
| City | Madison |
| State | NJ |
| Openfda › Nui › 1 | N0000193985 |
| Openfda › Nui › 2 | N0000193986 |
| Openfda › Unii | GK1LYB375A |
| Openfda › Route | SUBCUTANEOUS |
| Openfda › Rxcui › 1 | 2589378 |
| Openfda › Rxcui › 2 | 2589384 |
| Openfda › Rxcui › 3 | 2686061 |
| Openfda › Rxcui › 4 | 2686065 |
| Openfda › Spl id | 8abedac8-f75e-42a0-8591-10fabcf41fb5 |
| Openfda › Brand name | ADBRY |
| Openfda › Spl set id | d8020b69-3001-44e2-9b5d-5f93d9aaf6e1 |
| Openfda › Package ndc › 1 | 50222-346-01 |
| Openfda › Package ndc › 2 | 50222-346-02 |
| Openfda › Package ndc › 3 | 50222-346-22 |
| Openfda › Package ndc › 4 | 50222-346-04 |
| Openfda › Package ndc › 5 | 50222-346-91 |
| Openfda › Package ndc › 6 | 50222-346-92 |
| Openfda › Package ndc › 7 | 50222-350-00 |
| Openfda › Package ndc › 8 | 50222-350-01 |
| Openfda › Package ndc › 9 | 50222-350-02 |
| Openfda › Package ndc › 10 | 50222-350-90 |
| Openfda › Package ndc › 11 | 50222-350-91 |
| Openfda › Product ndc › 1 | 50222-346 |
| Openfda › Product ndc › 2 | 50222-350 |
| Openfda › Generic name | TRALOKINUMAB-LDRM |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | TRALOKINUMAB |
| Openfda › Pharm class epc | Interleukin-13 Antagonist [EPC] |
| Openfda › Pharm class moa | Interleukin-13 Antagonists [MoA] |
| Openfda › Manufacturer name | LEO Pharma Inc. |
| Openfda › Application number | BLA761180 |
| Openfda › Is original packager | true |
| Event id | 98401 |
| Address 1 | 7 Giralda Farms |
| Address 2 | N/A |
| Code info | Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027. |
| Postal code | 07940-1051 |
| Report date | 20260304 |
| Product type | Drugs |
| Product quantity | 11,407 units |
| Reason for recall | Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260210 |
| Initial firm notification | |
| Center classification date | 20260223 |
Overview
- Recalling FirmLEO PHARMA INC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA