Cisatracurium 20 mg multiple-dose vials recalled after subpotent assay results
Somerset Therapeutics is recalling 71,310 vials of Cisatracurium Besylate Injection, 20 mg/10 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, 20 mg/10 mL (2 mg/mL), supplied as 10 x 10 mL multiple-dose vials per carton, manufactured for Somerset Therapeutics, LLC of Hollywood, Florida, made in India, under NDC 70069-161-01, 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 71,310 10mL vials from lot A250043, expiry 06/30/2026. 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 lot 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 (2)
- Lot#: A250043
- EXP Date 06/30/2026
UPCs (2)
- 0370069161012
- 0370069161104
Distribution
Distributed nationwide across the United States.
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