The Recall Desk
HighFDA (Drugs)·D-1068-2023·Announced 2023-08-09

Morphine Injection Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services Inc. is recalling morphine injections nationwide due to inadequate validation of sterilization procedures, which poses a potential sterility risk.

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 recall with lack of sterility assurance in an injectable drug product. No illnesses or injuries reported, but this is a risk-of-harm product where sterility failures in injectables could cause serious infection.

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling morphine in 0.9% sodium chloride (125 mg/25 mL, 5 mg/mL strength) supplied in 30 mL syringes. The recall affects 723 syringes distributed nationwide in the United States.

The recall was initiated because the manufacturer lacks validation data for sanitization cycles used in the manufacturing process. This means there is no documented assurance that the sterilization procedures are effective, creating a potential risk that the product may not be sterile.

Affected lots are: 17-271060 (expires 7/24/2023), 17-271252 (expires 7/26/2023), 17-271571 (expires 8/1/2023), 17-272471 (expires 8/16/2023), and 17-272785 (expires 8/22/2023). Patients and healthcare providers in possession of this product should stop use immediately and consult their healthcare provider if it has already been administered.

Healthcare facilities should identify and quarantine affected units. For more information, contact Central Admixture Pharmacy Services Inc. at 7935 Dunbrook Road, Suite C, San Diego, CA 92126.

The recalled product

Product
morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2041-2
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable Pharmaceutical
Hazard
  • sterility-assurance
  • contamination-risk

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 (10)

  • Lot: 17-271060
  • Exp. 7/24/2023
  • 17-271252
  • Exp. 7/26/2023
  • 17-271571
  • Exp. 8/1/2023
  • 17-272471
  • Exp. 8/16/2023
  • 17-272785
  • Exp. 8/22/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category