Prescription Drug Recall: EVENITY Injection Due to Temperature Excursion Risk
Mckesson is recalling EVENITY (romosozumab-aqqg) injectable medication due to manufacturing compliance deviations and potential temperature excursions during shipping. The recall affects lot 1178382 distributed to Ohio, Virginia, and Florida.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification indicates potential for serious adverse health consequences. The manufacturing deviations and potential temperature excursions could affect drug stability and effectiveness. However, no illnesses or injuries have been reported, limiting the score to 3 per the rubric.
Plain-English summary
EVENITY (romosozumab-aqqg), a prescription injectable medication, is being recalled by Mckesson Medical-Surgical Inc. The recall is due to Current Good Manufacturing Practice (CGMP) deviations and potential temperature excursions that occurred during product transit.
The affected product is lot 1178382 (2 pre-filled syringes per package) with an expiration date of March 31, 2027. This lot was distributed within the United States in Ohio, Virginia, and Florida.
The product is manufactured by Amgen Inc. and is administered by subcutaneous injection for treating osteoporosis in postmenopausal women. Temperature fluctuations during shipping could affect the stability of the injectable medication.
The recalled product
- Product
- EVENITY (ROMOSOZUMAB-AQQG)
- Brand
- EVENITY
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
- Hazard
- cgmp-deviation
- temperature-excursion
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 1178382
- Expiration date: 3/31/2027
Distribution
Distributed in 3 states:
- FL
- OH
- VA
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