Benlysta vials recalled after potential temperature excursions during transit delays
Benlysta (belimumab) for injection 400 mg/20 mL is being recalled because of CGMP deviations involving potential temperature excursions due to transit delays. 3 vials 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
Benlysta (belimumab) for injection, 400 mg/20 mL vial, prescription only, NDC 49401-102-01, from GSK, is being recalled. The action covers 3 vials.
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 YK4W, expiring 4/30/2029. 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 GSK.
The recalled product
- Product
- BENLYSTA (BELIMUMAB)
- Brand
- BENLYSTA
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable biologic
- Affected units
- 3
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: YK4W
- Expiration date: 4/30/2029
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.
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