The Recall Desk
HighFDA (Drugs)·D-0954-2023·Announced 2023-08-09

EPINEPHrine IV bags recalled nationwide due to lack of sterility assurance

Central Admixture Pharmacy Services is recalling 9,121 epinephrine IV bags distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.

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: FDA Class II recall of an injectable product with unvalidated decontamination processes. No illnesses or hospitalizations reported in the source material, so per rubric criteria this rates as High (score 3) rather than Severe, as the hazard remains theoretical rather than realized.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 9,121 bags of EPINEPHrine 4mg/250mL added to 0.9% sodium chloride IV bags distributed nationwide. The recall was initiated because the manufacturer lacks assurance of sterility and has not provided adequate validation data for decontamination cycles used in the compounding process.

These are prescription-only injectable medications supplied to hospitals and other healthcare facilities. The affected lots have expiration dates ranging from July 2023 through September 2023.

Healthcare facilities that received any of the affected lots should immediately discontinue use and quarantine the product for return to the manufacturer or their pharmaceutical supplier. Verify inventory against the affected lot numbers and expiration dates provided in the recall notice.

The recalled product

Product
EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable / Compounded
Hazard
  • sterility-assurance
  • contamination-risk
  • compounding-defect

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: 36-239250
  • Exp. 7/10/2023
  • 36-240225
  • Exp.7/16/2023
  • 36-241268
  • 36-241270
  • Exp. 7/19/2023
  • 36-241443
  • Exp. 7/20/2023
  • 36-242436
  • 36-242439
  • Exp. 7/25/2023
  • 36-243517
  • 36-243738
  • Exp. 7/30/2023
  • 36-245656
  • Exp. 8/2/2023
  • 36-246154
  • 36-246169
  • 36-246672

Distribution

Distributed nationwide across the United States.

Related recalls

Same category