FDARecalled Jul 30, 2025 · #D-0538-2025
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Hazard
Class II — temporary health risk
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CGMP Deviations; potential temperature excursions due to transit delays Classification: Class II Distribution: Within the U.S - OH, VA, FL.
Product details
- Product
- PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
- Type
- Drugs
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Model numbers
- 1180924
- UPCs
- —