The Recall Desk
HighFDA (Drugs)·D-0714-2023·Announced 2023-05-31

FDA Recalls Norepinephrine Injection Due to Sterility Assurance Concerns

Central Admixture Pharmacy Services is recalling 2,041 bags of norepinephrine injection nationwide due to FDA concerns about product sterility. Healthcare providers should immediately stop using affected lots.

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 for an injectable medication where sterility assurance was called into question by regulatory inspection. No illnesses or injuries have been reported. Per the rubric, lack of reported illness with a theoretical hazard for a risk-of-harm product warrants a score of 3 (High).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 2,041 bags of norepinephrine 4 mg added to dextrose 5% injection (250 mL, 16 mcg/mL, NDC 71285-6056-1) distributed nationwide. The recall affects six manufacturing lots with expiration dates ranging from May 5, 2023 to June 13, 2023.

The FDA initiated the recall after an inspection of the manufacturer raised concerns about the sterility assurance of this product. Norepinephrine is a critical medication administered intravenously, and sterility is essential for patient safety.

Healthcare facilities and healthcare providers who have the affected lots should immediately stop administering the product and verify lot numbers and expiration dates. The affected lots are: 37-884760 (Exp 05/05/2023), 37-885601 (Exp 05/09/2023), 37-887668 (Exp 05/17/2023), 37-889594 (Exp 05/24/2023), 37-892622 (Exp 06/06/2023), and 37-894316 (Exp 06/13/2023). The FDA and manufacturer recommend returning product to the distributor or disposing of it according to institutional protocols.

The recalled product

Product
norepinephrine 4 mg added to dextrose 5% 250 mL*, 16 mcg/mL, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6056-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable / IV
Hazard
  • lack-of-sterility-assurance
  • 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 (12)

  • Lot # 37-884760
  • Exp 05/05/2023
  • 37-885601
  • Exp 05/09/2023
  • 37-887668
  • Exp 05/17/2023
  • 37-889594
  • Exp 05/24/2023
  • 37-892622
  • Exp 06/06/2023
  • 37-894316
  • Exp 06/13/2023

Distribution

Distributed nationwide across the United States.

Related recalls

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