FDA Recalls Succinylcholine Injection Lot Due to Decreased Preservative Concentration
One lot of Succinylcholine Chloride Injection was recalled for decreased preservative concentration found during stability testing. This could increase contamination risk in multi-dose vials.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with theoretical risk of microbial contamination from decreased preservative concentration. No reported illnesses or injuries documented. The score reflects the risk-of-harm nature of this injectable drug product where injury has not yet been reported.
Plain-English summary
Succinylcholine Chloride Injection is an injectable anesthetic agent used to relax muscles during anesthesia and certain medical procedures. Dr. Reddy's Laboratories, Inc. is recalling Lot K250048 of this product. The affected lot consists of 571 vials of the 200 mg/10 mL formulation and was distributed nationwide in the United States.
During 6-month stability testing, the manufacturer identified an out-of-specification (OOS) result in the affected lot. The testing revealed a decreased preservative concentration compared to specifications. Preservatives in multi-dose injectable vials prevent microbial contamination when the vial is accessed multiple times for patient use.
Healthcare providers who received Lot K250048 should discontinue use of this product immediately. Healthcare facilities should contact Dr. Reddy's Laboratories or the FDA for return instructions and information on obtaining replacement product.
The recalled product
- Product
- SUCCINYLCHOLINE (SUCCINYLCHOLINE)
- Brand
- SUCCINYLCHOLINE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Injectable Anesthetic
- Hazard
- decreased-preservative
- contamination-risk
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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