The Recall Desk
HighFDA (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.

What this means for you

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

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.

Related recalls

Same category