The Recall Desk
HighFDA (Drugs)·D-1052-2023·Announced 2023-08-09

FDA Recalls Hydromorphone Injectable Solution Due to Sterility Validation Failure

The FDA has recalled 3,824 bags of hydromorphone injectable solution due to lack of validated sterilization processes. The affected product may not meet required sterility assurance standards.

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 of an injectable opioid pharmaceutical. The hazard—lack of validated sterilization—represents a high-risk scenario for injectable products. However, the source reports no illnesses, hospitalizations, or confirmed contamination, placing the recall at the 'High' level per 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 HYDROmorphone injectable solution (10 mg/50 mL, 0.2 mg/mL, 100 mL bags) distributed nationwide. The recall was initiated due to lack of assurance of sterility resulting from missing validation data for the sanitization cycles used in product preparation.

The affected product was distributed nationwide. The recall involves 3,824 bags with multiple lot numbers and expiration dates ranging from July 31, 2023 to September 11, 2023.

Healthcare facilities, hospitals, pharmacies, and healthcare providers who have received this product should discontinue use immediately. The product should not be dispensed to or administered to patients.

The recalled product

Product
HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-3
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable Opioid
Hazard
  • lack-of-sterility
  • 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: 17-270599
  • 17-270600
  • Exp. 7/17/2023
  • 17-270785
  • Exp. 7/19/2023
  • 17-270969
  • Exp. 7/23/2023
  • 17-271116
  • 17-271135
  • Exp. 7/25/2023
  • 17-271242
  • Exp. 7/26/2023
  • 17-271502
  • Exp. 7/31/2023
  • 17-271561
  • 17-271589
  • Exp. 8/1/2023
  • 17-271672
  • Exp. 8/2/2023
  • 17-271837

Distribution

Distributed nationwide across the United States.

Related recalls

Same category