Rocuronium Injectable Drug Recalled Due to Sterility Assurance Failure

Plain-English summary

The FDA has issued a Class II recall of rocuronium 50 mg/5 mL injectable syringes due to lack of sterility assurance. The product, repackaged by Central Admixture Pharmacy Services, Inc. in Phoenix, Arizona, was distributed nationwide.

The recall was initiated because the manufacturer lacks validation data demonstrating that the sterilization and sanitization processes used in repackaging the drug are effective. This creates a potential risk that the syringes may not be sterile, which is a critical requirement for injectable medications.

The affected product includes 3,519 syringes from lots 36-262729, 36-262982, 36-262981, 36-262732, 36-262731, and 36-262730, which expired in October 2023. Healthcare providers and patients who have this product should consult with their pharmacist or healthcare provider about proper disposal. Any suspected adverse events should be reported to the FDA MedWatch program.

The recalled product

Product

rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.

Manufacturer

Central Admixture Pharmacy Services, Inc.

Category

Drug

Hazard

• lack-of-sterility
• 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.

Distribution

Distributed nationwide across the United States.

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