The Recall Desk
HighFDA (Drugs)·D-0729-2023·Announced 2023-05-31

Epinephrine Injection Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling epinephrine injection (4 mg/250 mL) following FDA inspection findings that the product's sterility cannot be assured.

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 a sterile injectable medication where FDA inspection raised concerns about sterility assurance. While no illnesses or injuries have been reported, lack of sterility assurance for injectable products poses significant risk of infection if contaminated, meeting the criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 5,627 bags of epinephrine added to dextrose 5% (4 mg/250 mL) with NDC 71285-7018-1. The product is a sterile injectable medication distributed nationwide in the USA.

The recall was initiated following an FDA inspection that raised questions about whether the sterility of the product could be assured. Sterile injectable medications must maintain strict sterility standards to ensure safety.

Healthcare facilities and providers that have received affected lots should discontinue use immediately. The affected lot numbers and expiration dates are: 37-883218 (04/30/2023), 37-885235 (05/08/2023), 37-885923 (05/10/2023), 37-889050 (05/23/2023), 37-890053 and 37-890054 (05/28/2023), 37-891439 and 37-891441 (06/01/2023), 37-892500 (06/06/2023), 37-894308 (06/13/2023), 37-896125 (06/20/2023), 37-896926 (06/22/2023), and 37-900396 (07/06/2023).

The recalled product

Product
EPINEPHrine added to dextrose 5%, 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 71285-7018-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Sterile Injectable
Hazard
  • sterility-assurance-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 # 37-883218
  • Exp 04/30/2023
  • 37-885235
  • Exp 05/08/2023
  • 37-885923
  • Exp 05/10/2023
  • 37-889050
  • Exp 05/23/2023
  • 37-890053
  • 37-890054
  • Exp 05/28/2023
  • 37-891439
  • 37-891441
  • Exp 06/01/2023
  • 37-892500
  • Exp 06/06/2023
  • 37-894308
  • Exp 06/13/2023
  • 37-896125
  • Exp 06/20/2023

Distribution

Distributed nationwide across the United States.

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