FDA Drugs recall ·
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL… recall
- Recall number
- D-0116-2025
- Date
- (initiated September 11, 2024)
- Company / brand
- Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive, Richmond, VA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 5 cartons/20 units each carton
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04
Why was it recalled?
cGMP Deviations: Temperature excursion
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Serial # 100000831961 100000820688 100000820689 100000820515
Distribution
Virgina
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0116-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.