The Recall Desk
HighFDA (Drugs)·D-0029-2024·Announced 2023-10-11

HYDROmorphone Syringes Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling 4,550 syringes of HYDROmorphone due to lack of assurance of sterility. The product was distributed nationwide.

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: FDA Class II recall of injectable medication due to lack of sterility assurance. No reported hospitalizations or significant injuries. Classified as a risk-of-harm product without reported injury, matching the rubric criterion for High (3).

Plain-English summary

Central Admixture Pharmacy Services Inc is recalling HYDROmorphone 15 mg/30 mL in 30 mL syringes (NDC 71286-2011-1) distributed nationwide. The recall affects approximately 4,550 syringes.

The recall is due to lack of assurance of sterility. HYDROmorphone is an opioid pain medication typically administered intravenously. Injectable medications must maintain strict sterile conditions to prevent contamination and potential infection.

The affected lot numbers are: 17-275315 (expires 10/3/2023), 17-275466 (expires 10/4/2023), 17-275477 (expires 10/4/2023), 17-276102 (expires 10/17/2023), and 17-276221 (expires 10/19/2023). The product was manufactured by Central Admixture Pharmacy Services Inc, located at 7935 Dunbrook Road, Suite C, San Diego, CA 92126.

Patients and healthcare providers should cease use of affected syringes and consult their healthcare provider regarding further guidance.

The recalled product

Product
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
Manufacturer
Central Admixture Pharmacy Services Inc
Hazard
  • sterility-failure
  • infection-risk

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 (9)

  • Lot:17-275315
  • Exp.10/3/2023
  • 17-275466
  • 17-275477
  • Exp.10/4/2023
  • 17-276102
  • Exp. 10/17/2023
  • 17-276221
  • Exp. 10/19/2023

Distribution

Distributed nationwide across the United States.