The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1049-2023·Announced 2023-08-09

Compounded HYDROmorphone Syringes Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling 2,228 HYDROmorphone injectables (0.1 mg/mL) due to lack of validation data for sanitization cycles affecting sterility assurance. Multiple lot numbers distributed nationwide are affected.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 Class II recall of an injectable compounded medication where lack of sterility assurance poses inherent patient risk. However, no illnesses, injuries, or hospitalizations have been reported, so per the rubric, the score is capped at 3 for theoretical hazards without confirmed harm.

Plain-English summary

Central Admixture Pharmacy Services Inc is recalling HYDROmorphone in dextrose 5% (3 mg/30 mL, 0.1 mg/mL concentration) supplied in 30 mL syringes. The affected product is an injectable compounded medication with NDC 71286-2013-2. A total of 2,228 syringes from multiple lot numbers have been distributed nationwide.

The recall was initiated due to lack of assurance of sterility. Specifically, there was a lack of validation data for the firm's sanitization cycles used in the compounding process. This validation gap means there is inadequate documentation that the sanitization procedures effectively eliminate microorganisms from equipment used to prepare the medication.

Healthcare providers and facilities that received this product should check their inventory against the affected lot numbers and expiration dates. Any unused product from these lots should be quarantined and not administered to patients. Patients or healthcare providers who believe they may have received a dose from an affected lot should contact their healthcare provider immediately.

The recalled product

Product
HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable Compounded
Hazard
Affected units
2,228

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: 17-270675
  • 17-270683
  • Exp. 7/18/2023
  • 17-271147
  • 17-271119
  • Exp. 7/25/2023
  • 17-271339
  • Exp. 7/27/2023
  • 17-271679
  • Exp. 8/2/2023
  • 17-272202
  • Exp. 8/10/2023
  • 17-272241
  • Exp. 8/13/2023
  • 17-272375
  • Exp. 8/15/2023
  • 17-272783
  • Exp. 8/22/2023
  • 17-273438
  • 17-273431

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 39 recalled by Central Admixture Pharmacy Services Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 39 products in this recall →

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