The Recall Desk
HighFDA (Drugs)·D-1044-2023·Announced 2023-08-09

HYDROmorphone Injectable Syringes Recalled Due to Sterility Assurance Concerns

Central Admixture Pharmacy Services Inc is recalling HYDROmorphone injectable syringes because sterilization cycles were not validated. The recall affects 2,717 units 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: This is a FDA Class II recall with no reported illnesses or injuries. The hazard (lack of sterility assurance) represents a significant risk to patients from an injectable medication but has not yet resulted in documented harm. Per the severity rubric, a risk-of-harm product without reported injury warrants a High (3) rating.

Plain-English summary

Central Admixture Pharmacy Services Inc is recalling HYDROmorphone (0.2 mg/mL) in 0.9% sodium chloride supplied in 30 mL syringes. A total of 2,717 syringes were distributed nationwide.

The recall was initiated because sanitization cycles were not validated, meaning the sterilization process was not properly tested or documented. This creates a potential risk that the product may not be sterile as required for injectable medications.

The affected product was distributed to healthcare facilities nationwide. Patients and providers in possession of the recalled lots should discontinue use immediately. The recalled lots include 11 specific batch numbers with expiration dates from July through September 2023.

Individuals affected by this recall should contact their healthcare provider or pharmacy for instructions. The manufacturer and FDA recommend proper disposal of any remaining product from the recalled lots.

The recalled product

Product
HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable
Hazard
  • sterility-assurance
  • microbial-contamination

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: 17-270603
  • Exp. 7/17/2023
  • 17-270802
  • Exp. 7/19/2023
  • 17-271073
  • Exp. 7/24/2023
  • 17-271129
  • Exp. 7/25/2023
  • 17-271254
  • Exp. 7/26/2023
  • 17-271953
  • Exp. 8/8/2023
  • 17-272022
  • Exp. 8/9/2023
  • 17-272295
  • Exp. 8/14/2023
  • 17-272616
  • Exp. 8/20/2023
  • 17-273357
  • Exp. 8/31/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category