The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0745-2023·Announced 2023-05-31

Drug Recall: NORepinephrine Injectable Solution Due to Sterility Concerns

Central Admixture Pharmacy Services is recalling NORepinephrine injectable solution nationwide after an FDA inspection questioned the product's sterility assurance. The recall affects 4,994 bags.

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 recall with no reported illnesses or injuries. The hazard—lack of sterility assurance in a medication product—represents a risk-of-harm where injury has not yet been reported, fitting the 'High' severity criterion.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling NORepinephrine added to 0.9% sodium chloride (4 mg/250 mL, 16 mcg/mL, 250 mL per bag, Rx only). The recall is due to lack of assurance of sterility: an FDA inspection called into question the sterility of products intended to be sterile.

The affected product was distributed nationwide in the United States. The recall affects 4,994 bags, identified by 14 lot numbers with expiration dates ranging from May 2023 through July 2023.

Healthcare facilities and patients who have received this product should not use it. Consult with your healthcare provider regarding this recall.

The recalled product

Product
NORepinephrine added to 0.9% sodium chloride, 4 mg/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 71285-8097-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable medication
Hazard
Affected units
4,994

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 # 37-884510
  • Exp 05/04/2023
  • 37-885671
  • Exp 05/09/2023
  • 37-886285
  • Exp 05/11/2023
  • 37-888322
  • Exp 05/21/2023
  • 37-888851
  • Exp 05/22/2023
  • 37-889840
  • Exp 05/25/2023
  • 37-890130
  • Exp 05/28/2023
  • 37-890966
  • Exp 05/30/2023
  • 37-893529
  • Exp 06/11/2023
  • 37-894766
  • Exp 06/14/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 108 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 108 products in this recall →

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Same manufacturer · Central Admixture Pharmacy Services, Inc.

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