Succinylcholine chloride injection recalled after preservative concentration fell out of specification
Dr. Reddy's is recalling 571 vials of Succinylcholine Chloride Injection USP after an out-of-specification result for decreased preservative concentration at six-month stability testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 as a specification failure: the record reports an out-of-specification stability result without describing a health consequence or reporting injury.
Plain-English summary
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), supplied as 25 x 10 mL multiple-dose vials for intravenous or intramuscular use, distributed by Dr. Reddy's Laboratories of Princeton, New Jersey, is being recalled.
The recall follows an out-of-specification result during six-month stability testing, showing decreased preservative concentration.
The recall covers 571 vials from lot K250048, carrying NDC 43598-666-25, distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record states the stability testing result without describing a health consequence, and reports no injuries. Facilities holding the affected lot should follow the firm's instructions.
The recalled product
- Product
- SUCCINYLCHOLINE (SUCCINYLCHOLINE)
- Brand
- SUCCINYLCHOLINE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Injectable
- Affected units
- 571
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 (1)
- Lot # K250048
UPCs (2)
- 0343598666259
- 0343598666112
Distribution
Distributed nationwide across the United States.
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