The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1064-2023·Announced 2023-08-09

Morphine Syringes Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 1,699 morphine syringes nationwide due to lack of validated sanitization cycles, which may compromise sterility assurance.

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: FDA Class II pharmaceutical recall of a sterile injection product with unvalidated sterilization processes, creating risk of harm. No illnesses or injuries have been reported, placing this at score 3 per the rubric for risk-of-harm products without reported injury.

Plain-English summary

Central Admixture Pharmacy Services Inc is recalling morphine 1 mg/mL in 0.9% sodium chloride 3 mL syringes (NDC 71286-2040-1) distributed nationwide. The recall affects 1,699 syringes across six lots.

The recall was initiated because the manufacturer lacked adequate validation data for the sanitization cycles used in manufacturing. This creates a lack of assurance that the syringes meet required sterility standards. Sterile pharmaceutical injections manufactured without validated sterilization processes may not be safe for patient use.

Affected lot numbers and expiration dates are: 17-270804 (Exp. 7/19/2023), 17-271108 (Exp. 7/25/2023), 17-271496 (Exp. 7/31/2023), 17-271844 (Exp. 8/6/2023), 17-272045 (Exp. 8/9/2023), and 17-272288 (Exp. 8/14/2023).

Patients and healthcare providers who have this product should contact Central Admixture Pharmacy Services Inc or their healthcare provider for guidance on proper handling and next steps.

The recalled product

Product
morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-1
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable Medication
Hazard
Affected units
1,699

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 (12)

  • Lot: 17-270804
  • Exp. 7/19/2023
  • 17-271108
  • Exp. 7/25/2023
  • 17-271496
  • Exp. 7/31/2023
  • 17-271844
  • Exp. 8/6/2023
  • 17-272045
  • Exp. 8/9/2023
  • 17-272288
  • Exp. 8/14/2023.

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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