Evenity recall: CGMP Deviations
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC…
Why was Evenity recalled?
CGMP Deviations; potential temperature excursions due to transit delays
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 1178382, Expiration date: 3/31/2027
- Product
- EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC…
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Quantity
- 2 Pre-filled syringes
- Distribution
- Within the U.S - OH, VA, FL.
- Recall date
- July 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)