The Recall Desk
HighFDA (Drugs)·D-0730-2023·Announced 2023-05-31

Prescription Injectable Epinephrine and Dextrose Solution Recalled for Sterility Assurance Failure

Central Admixture Pharmacy Services has recalled nationwide 2,542 bags of prescription-only injectable epinephrine and dextrose solution due to lack of sterility assurance following an FDA inspection.

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 lack of sterility assurance in a prescription injectable medication following an inspection. No illnesses or injuries have been reported. As a risk-of-harm product where injury has not yet been reported, it meets the rubric criterion for a score of 3.

Plain-English summary

EPINEPHrine added to dextrose 5% (8 mg/250 mL, 32 mcg/mL) in 250 mL bags manufactured by Central Admixture Pharmacy Services, Inc. has been recalled. This prescription-only injectable medication was distributed nationwide.

An FDA inspection determined that the manufacturer could not provide assurance that these products meet sterility requirements.

The recalled medication was distributed nationwide. Ten affected lot numbers have been identified: 37-884156 (Exp 05/03/2023), 37-885207 (Exp 05/08/2023), 37-885929 (Exp 05/10/2023), 37-886496 (Exp 05/14/2023), 37-886817 (Exp 05/15/2023), 37-887420 (Exp 05/16/2023), 37-893786 (Exp 06/12/2023), 37-894303 (Exp 06/13/2023), 37-897893 (Exp 06/27/2023), and 37-900073 (Exp 07/05/2023).

Patients who received this medication should contact their healthcare provider.

The recalled product

Product
EPINEPHrine added to dextrose 5%, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7019-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable Medication
Hazard
  • sterility-failure

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 # 37-884156
  • Exp 05/03/2023
  • 37-885207
  • Exp 05/08/2023
  • 37-885929
  • Exp 05/10/2023
  • 37-886496
  • Exp 05/14/2023
  • 37-886817
  • Exp 05/15/2023
  • 37-887420
  • Exp 05/16/2023
  • 37-893786
  • Exp 06/12/2023
  • 37-894303
  • Exp 06/13/2023
  • 37-897893
  • Exp 06/27/2023
  • 37-900073
  • Exp 07/05/2023

Distribution

Distributed nationwide across the United States.

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