The Recall Desk
HighFDA (Drugs)·D-0734-2023·Announced 2023-05-31

NORepinephrine Injectable Recalled Nationwide for Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 6,341 bags of NORepinephrine nationwide due to FDA concerns about sterility assurance. An FDA inspection found the manufacturer could not adequately ensure the product's 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 with no reported illnesses or hospitalizations. The hazard—inability to assure sterility in a parenteral injectable drug—is serious and risk-causing, fitting the criterion for score 3: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 6,341 bags of NORepinephrine (16 mg/250 mL) distributed nationwide in the United States. The product is supplied in 250 mL bags for sterile intravenous use. Multiple lot numbers are affected, with expiration dates ranging from April 2023 through July 2023.

The FDA conducted an inspection of the manufacturer's facility and determined that the company could not provide adequate assurance of sterility for the recalled products. Sterile injectable drugs must meet stringent manufacturing and quality control standards to prevent serious infections from contamination.

Healthcare facilities and pharmacies that received the affected lots should identify and quarantine those products. Patients and healthcare providers should not use the recalled product. Information about the specific lot numbers included in this recall is available from the manufacturer and FDA.

The recalled product

Product
NORepinephrine added to 0.9% sodium chloride, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7036-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Sterile Injectable
Hazard
  • sterility-failure
  • infection-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 (20)

  • Lot # 37-882998
  • 37-883005
  • 37-883145
  • Exp 04/28/2023
  • 37-883144
  • 37-883220
  • 37-883221
  • 37-883222
  • Exp 04/30/2023
  • 37-883925
  • Exp 05/02/2023
  • 37-884180
  • 37-884181
  • Exp 05/03/2023
  • 37-884505
  • 37-884506
  • 37-884507
  • 37-884508
  • 37-884509
  • Exp 05/04/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category