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.
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 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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