The Recall Desk
HighFDA (Drugs)·D-1058-2023·Announced 2023-08-09

HYDROmorphone Injection Recall Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 2,077 syringes of HYDROmorphone injection (15 mg/30 mL) distributed nationwide due to lack of validation data for sanitization cycles. No adverse events have been reported.

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 an FDA Class II recall without reported illnesses or injuries. The hazard—lack of sterility assurance due to inadequate sanitization validation—represents a potential risk to patients, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling 2,077 syringes of HYDROmorphone in 0.9% sodium chloride (15 mg/30 mL, 0.5 mg/mL) supplied as 30 mL syringes distributed nationwide in the USA. The product is a prescription injectable opioid medication (NDC 71286-2011-1).

The recall was initiated due to lack of assurance of sterility. The manufacturer lacked adequate validation data for the sanitization cycles used in production. Sterile injectable products require documented proof that sterilization and sanitization processes are effective and reliable.

The affected lots are: 17-270770 (Exp. 7/19/2023), 17-271061 (Exp. 7/24/2023), 17-271419 (Exp. 7/30/2023), 17-271678 (Exp. 8/2/2023), 17-272124 (Exp. 8/10/2023), 17-272302 (Exp. 8/14/2023), 17-272518 (Exp. 8/17/2023), 17-273493 (Exp. 9/4/2023), and 17-273671 (Exp. 9/6/2023). Healthcare providers and patients should consult their healthcare provider if they have received this product. The FDA has not received any adverse event reports related to this recall.

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
Category
Drug — Injectable / Opioid
Hazard
  • contamination
  • sterility-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 (18)

  • Lot: 17-270770
  • Exp. 7/19/2023
  • 17-271061
  • Exp. 7/24/2023
  • 17-271419
  • Exp. 7/30/2023
  • 17-271678
  • Exp. 8/2/2023
  • 17-272124
  • Exp. 8/10/2023
  • 17-272302
  • Exp. 8/14/2023
  • 17-272518
  • Exp. 8/17/2023
  • 17-273493
  • Exp. 9/4/2023
  • 17-273671
  • Exp. 9/6/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category