The Recall Desk
HighFDA (Drugs)·D-1080-2023·Announced 2023-08-09

Morphine Injectable Recalled Due to Unvalidated Sterilization Process

Central Admixture Pharmacy Services recalls 1,235 morphine syringes nationwide due to lack of validation data for sterilization cycles, potentially compromising 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: This is an FDA Class II recall of an injectable medication with a critical sterilization validation failure. While no illnesses or injuries have been reported, the lack of validated sterilization processes presents a significant risk of harm through potential bacterial or fungal contamination, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling 1,235 syringes of morphine in 0.9% sodium chloride (50 mg/50 mL), distributed nationwide. The recall was initiated because the manufacturer lacks validation data for the sanitization cycles used in the manufacturing process.

The concern is the lack of assurance of sterility. Without proper validation of the sanitization process, the manufacturer cannot confirm that the sterilization is effective, which could potentially leave injectable products contaminated with bacteria or fungi.

The affected product lots are: 17-273353 (expires 8/31/2023), 17-270602 (expires 7/17/2023), 17-270706 (expires 7/18/2023), 17-271416 (expires 7/30/2023), 17-272049 (expires 8/9/2023), 17-272277 (expires 8/14/2023), and 17-273231 (expires 8/30/2023).

Patients and healthcare providers should not use affected syringes. Contact your pharmacy or healthcare provider for guidance on replacement or proper disposal.

The recalled product

Product
morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2040-4
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable Medication
Hazard
  • sterilization-failure
  • 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 (14)

  • Lot: 17-273353
  • Exp 8/31/2023
  • 17-270602
  • Exp 7/17/2023
  • 17-270706
  • Exp 7/18/2023
  • 17-271416
  • Exp 7/30/2023
  • 17-272049
  • Exp 8/9/2023
  • 17-272277
  • Exp 8/14/2023
  • 17-273231
  • Exp 8/30/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category