Prolia prefilled syringes recalled after potential temperature excursions during transit delays
Prolia (denosumab) injection 60 mg/mL is being recalled because of CGMP deviations involving potential temperature excursions due to transit delays. 6 pre-filled syringes are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall over a potential temperature excursion in transit, with no confirmed potency or stability failure stated in the source.
Plain-English summary
Prolia (denosumab) injection, 60 mg/mL, for subcutaneous use only, prescription only, manufactured by Amgen Inc. of Thousand Oaks, California, NDC 55513-710-21, is being recalled. The action covers 6 pre-filled syringes.
The stated reason is CGMP deviations: potential temperature excursions due to transit delays. The FDA classified the action as Class II. The source does not report any confirmed loss of potency or stability.
The affected lot is 1180924, expiring 6/30/2027. Distribution was within the US, in Ohio, Virginia and Florida.
Facilities should identify affected stock using the NDC and lot number above and follow the instructions issued by Amgen.
The recalled product
- Product
- PROLIA (DENOSUMAB)
- Brand
- PROLIA
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable biologic
- Affected units
- 6
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: 1180924
- Expiration date: 6/30/2027.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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