Dr. Reddy's Laboratories Inc. recalled 571 vials of Succinylcholine Chloride Injection, USP nationwide in the United States. The recall cites an out-of-specification result during six-month stability testing due to decreased preservative concentration. Healthcare providers and patients should stop using the product immediately and await guidance from the recall letter.
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Consumers and healthcare providers should stop using this product immediately. Contact Dr. Reddy's Laboratories, Inc. or your healthcare provider for guidance. Notification method: Letter
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Succinylcholine Chloride Injection is a short-acting neuromuscular blocker used to facilitate intubation and muscle relaxation during surgery. The product is distributed in multi-dose vials for hospital and clinical use.
The product showed an out-of-specification result in six-month stability testing, specifically a decrease in preservative concentration. This can raise concerns about sterility and potency of the injectable medication.
This recall is not described as part of a broader industry pattern in the notice.
Hospitals and surgical teams may need to identify alternative neuromuscular blocking agents and adjust procurement to replace the recalled lots.
Recall letters and identification details are available via the FDA recall page linked in the notice.
Replacement or discard instructions will be provided in the recall letter; typical recall timelines include weeks to months depending on facility.
Keep the recall letter, FDA notice, and correspondence with the distributor. Photograph and log the recalled lot and its disposition.
NDC 43598-666-25. Lot K250048. 25 x 10 mL multiple-dose vials. 200 mg/10 mL (20 mg/mL). For intravenous or intramuscular use. Rx Only. Distributed nationwide by Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.
No injuries or incidents have been reported.
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