Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations; potential temperature excursions due to transit delays
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.
Compare with the code on your package — it is the most precise check available.
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Evenity romosozumab-aqqg NDC 55513-0880 |
ROMOSOZUMAB 105 mg/1.17mL | Injection, Solution Subcutaneous |
Amgen, Inc | Rx |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
CGMP Deviations; potential temperature excursions due to transit delays
CGMP Deviations; potential temperature excursions due to transit delays
cGMP deviations: Temperature excursion during transportation.
Temperature Abuse
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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