Cisatracurium 10 mg vials recalled after subpotent stability assay results
Somerset Therapeutics is recalling 52,340 vials of Cisatracurium Besylate Injection, 10 mg/5 mL, after out of specification assay results during long term stability testing.
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: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites a subpotent assay result with no stated clinical consequence.
Plain-English summary
Cisatracurium Besylate Injection USP, 10 mg/5 mL (2mg/mL), supplied as 10 x 5 mL single-dose vials per carton, manufactured for Somerset Therapeutics, LLC of Hollywood, Florida, made in India, under NDC 70069-141-01, is being recalled.
The reason given in the enforcement record is a subpotent product: out of specification assay results observed during long term stability testing.
The recall covers 52,340 5mL vials from lots A240438, expiry 1/31/26, and A250125, expiry 8/31/26. Distribution was nationwide in the USA. The FDA has classified the action as Class III, its least serious category.
The record describes a specification failure rather than a reported patient harm. Facilities should quarantine the affected lots and follow the firm's instructions.
The recalled product
- Product
- CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
- Brand
- CISATRACURIUM BESYLATE
- Manufacturer
- SOMERSET THERAPEUTICS LLC
- Category
- Drug — Neuromuscular blocker
- Hazard
- subpotent
- stability-failure
- out-of-specification
- class-iii
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 (4)
- Lot#: A240438
- Exp Date 1/31/26
- A250125
- Exp Date 8/31/26
UPCs (4)
- 0370069141014
- 0370069151013
- 0370069141106
- 0370069151105
Distribution
Distributed nationwide across the United States.
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