The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1055-2023·Announced 2023-08-09

Hydromorphone Injection Syringes Recalled for Sterility Validation Deficiency

Central Admixture Pharmacy Services is recalling 2,389 hydromorphone injection syringes distributed nationwide due to lack of validation data for sterilization procedures, which prevents assurance of product sterility.

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 an FDA Class II recall involving an injectable prescription drug with confirmed lack of sterilization validation data affecting nationwide distribution. However, no illnesses or injuries have been reported, and the hazard remains theoretical until contamination is confirmed, placing it in the High category per the rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 2,389 syringes of hydromorphone (10 mg/50 mL, 0.2 mg/mL concentration) distributed nationwide. The product is a prescription injectable medication supplied in 50 mL syringes.

The recall stems from a lack of validation data for the sterilization cycles used in manufacturing. Without this validation, the manufacturer cannot provide assurance that the product meets the sterility standards required for injectable medications.

Patients or healthcare providers who have these syringes should contact their pharmacy or healthcare provider immediately. The recall affects multiple lot numbers expiring between July and September 2023, including: 17-270530 (7/16/2023), 17-270871 (7/20/2023), 17-271153 (7/25/2023), 17-271275 (7/26/2023), 17-271417 (7/30/2023), 17-271671 (8/2/2023), 17-271883 (8/7/2023), 17-271992 (8/8/2023), 17-272050 (8/9/2023), 17-272103 (8/10/2023), 17-272368 and 17-272369 (8/15/2023), 17-272451 (8/16/2023), 17-273172 (8/29/2023), and 17-273782 (9/7/2023). Healthcare providers should verify their inventory against these lot numbers and consult with their pharmacist regarding handling and potential replacements.

The recalled product

Product
HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable Opioid
Hazard
Affected units
2,389

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 (20)

  • Lot: 17-270530
  • Exp. 7/16/2023
  • 17-270871
  • Exp. 7/20/2023
  • 17-271153
  • Exp. 7/25/2023
  • 17-271275
  • Exp. 7/26/2023
  • 17-271417
  • Exp. 7/30/2023
  • 17-271671
  • Exp. 8/2/2023
  • 17-271883
  • Exp. 8/7/2023
  • 17-271992
  • Exp. 8/8/2023
  • 17-272050
  • Exp. 8/9/2023
  • 17-272103
  • Exp. 8/10/2023

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 →

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