FDA Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for 1,350 syringes of Succinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection. The product is manufactured by KRS Global Biotechnology, Inc. and is distributed nationwide.

The recall was initiated because the manufacturer lacks assurance of the product's sterility. The affected product is identified by NDC 3321678417. The recall covers all lots remaining within their expiration dates.

Healthcare providers and patients should stop using the affected syringes and contact their healthcare provider or the manufacturer for further instructions. This recall is classified as Class II by the FDA.

The recalled product

Product

SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678417

Manufacturer

KRS Global Biotechnology, Inc

Category

Drug — Injectable Medication

Hazard

• sterility
• infection

Affected units

1,350

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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