The Recall Desk
HighFDA (Drugs)·D-1057-2023·Announced 2023-08-09

HYDROmorphone Injectable Syringes Recalled Due to Unvalidated Sanitization Cycles

Central Admixture Pharmacy is recalling HYDROmorphone injection syringes nationwide due to lack of validated sanitization cycles, which compromises sterility.

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 injectable drug recall for unvalidated sanitization cycles that could compromise product sterility. No illnesses or injuries reported in the source text. Hazard is theoretical, not based on confirmed contamination, so the severity is High rather than Severe.

Plain-English summary

Central Admixture Pharmacy Services Inc is recalling HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL, 5 mL syringes due to lack of assurance of sterility. The recall involves 1,389 syringes with lot numbers and expiration dates ranging from July to September 2023.

The recall is prompted by lack of validation data for sanitization cycles. Injectable pharmaceutical products must be manufactured under sterile conditions, and without validated sanitization procedures, the product's sterility cannot be assured.

The affected product was distributed nationwide in the United States. Patients and healthcare facilities in possession of affected lots should contact Central Admixture Pharmacy Services Inc or the FDA for guidance on proper handling and disposal of the recalled product.

The recalled product

Product
HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2013-1
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable
Hazard
Affected units
1,389

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 (16)

  • Lot: 17-270683
  • Exp 7/18/2023
  • 17-271119
  • Exp 7/25/2023
  • 17-271339
  • Exp 7/27/2023
  • 17-272202
  • Exp 8/10/2023
  • 17-272241
  • Exp 8/13/2023
  • 17-272783
  • Exp 8/22/2023
  • 17-273431
  • Exp 9/3/2023
  • 17-273615
  • Exp 9/5/2023

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 →

Related recalls

Same manufacturer · Central Admixture Pharmacy Services Inc

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Same hazard · sterility defect

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