HIGH

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,...

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.

Quick Facts at a Glance

Recall Date
February 10, 2026
Hazard Level
HIGH
Brands
ADBRY, LEO Pharma Inc.
Geographic Scope
1 states

Hazard Information

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.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact LEO PHARMA INC or your healthcare provider for guidance. Notification method: E-Mail

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Full Description

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,. Generic: TRALOKINUMAB-LDRM; Brand: ADBRY. Reason: 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.. Classification: Class II. Quantity: 11,407 units. Distribution: Nationwide in the USA

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Product Classification

Product Details

Model Numbers
Lot: a) 003E24C
Exp 04/30/2027
b) 003E24A
Exp 04/30/2027.
UPC Codes
50222-346
50222-350
50222-346-01
+9 more
Affected States
ALL
Report Date
March 4, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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