Agency classClass IIOur severity:High FDA (Drugs)·D-1060-2023·Announced 2023-08-09

HYDROmorphone Injectable Syringes Recalled for Lack of Sterilization Validation

Central Admixture Pharmacy Services is recalling 5,259 HYDROmorphone injectable syringes nationwide due to lack of validation data for sterilization, raising concerns about product sterility assurance.

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: This is a high-risk injectable drug product with potential sterility assurance issues due to missing validation data for sterilization. No illnesses or injuries have been reported. Per the rubric, when a hazard is theoretical and no injuries are documented, the maximum score is 3.

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling HYDROmorphone 1 mg/mL in 0.9% sodium chloride injectable syringes nationwide. The recall involves approximately 5,259 syringes with multiple lot numbers, each with expiration dates ranging from July through September 2023.

The product is being recalled due to lack of validation data for sanitization cycles, which creates insufficient assurance of sterility. For injectable medications, sterility is a critical requirement.

Anyone who may have received this product should contact their healthcare provider. Healthcare facilities should identify and quarantine any affected lots and follow manufacturer instructions for return or replacement.

The recalled product

Product: HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1
Manufacturer: Central Admixture Pharmacy Services Inc
Category: Drug — Injectable
Hazard: sterility-assurance
sterilization-failure
Affected units: 5,259

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 (20)

Lot: 17-270534
Exp. 7/16/2023
17-270705
Exp. 7/18/2023
17-270782
17-270797
17-270798
Exp. 7/19/2023
17-270968
Exp. 7/23/2023
17-271105
17-271154
Exp. 7/25/2023
17-271251
Exp. 7/26/2023
17-271330
Exp. 7/27/2023
17-271418
Exp. 7/30/2023
17-271746

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 39 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 39 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services Inc

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