The Recall Desk
HighFDA (Drugs)·D-1065-2023·Announced 2023-08-09

Morphine Injectable Syringes Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling 720 syringes of morphine due to lack of validation data for sanitization cycles, which creates uncertainty about product sterility. The product was distributed nationwide.

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 no reported illnesses or injuries. The hazard involves potential loss of sterility assurance in an injectable medication due to inadequate sanitization validation, which represents a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services Inc is recalling 720 syringes of morphine in 0.9% sodium chloride (30 mg/30 mL, 1 mg/mL concentration). The product is identified by NDC 71286-2040-3 and was distributed nationwide in the United States.

The recall was issued due to lack of assurance of sterility. Specifically, the manufacturer lacks validation data for the sanitization cycles used in producing the syringes. This creates uncertainty about whether the product meets required sterility standards for injectable use.

The affected lot numbers are 17-270814 (expiration 7/19/2023), 17-271253 (expiration 7/26/2023), 17-271336 (expiration 7/27/2023), and 17-271689 (expiration 8/2/2023). Individuals who have received injections from these syringes should contact their healthcare provider with any questions or concerns.

The recalled product

Product
morphine in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-3
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable
Hazard
  • sterility-failure
  • 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 (8)

  • Lot: 17-270814
  • Exp. 7/19/2023
  • 17-271253
  • Exp. 7/26/2023
  • 17-271336
  • Exp. 7/27/2023
  • 17-271689
  • Exp. 8/2/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category