Agency classClass IIOur severity:High FDA (Drugs)·D-1113-2023·Announced 2023-09-06

Rocuronium Injectable Drug Recalled Due to Sterility Assurance Failure

The FDA is recalling rocuronium injectable syringes due to unvalidated sterilization processes. The product was distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 for injectable pharmaceutical due to lack of validated sterilization and sanitization processes. This represents a significant risk of harm given the critical importance of sterility for injectable medications.

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
Affected units: 3,519

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 (7)

Lot# 36-262729
36-262982
36-262981
36-262732
36-262731
36-262730
Exp 10/11/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 32 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 32 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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