Agency classClass IIOur severity:High FDA (Drugs)·D-0959-2023·Announced 2023-08-09

EPINEPHrine IV Bags Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services, Inc. is recalling EPINEPHrine 8mg/250ml IV bags due to lack of sterility assurance and insufficient validation data for decontamination cycles. The recall affects 4,570 units distributed nationwide.

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 involving potential sterility issues with injectable medication. No illnesses or injuries have been reported in the source material, but the hazard presents significant risk due to the nature of sterile injectable pharmaceuticals and the lack of proper sterilization validation data.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling EPINEPHrine 8mg/250ml IV bags (32 mcg/mL in dextrose 5%). The manufacturer, located in Phoenix, Arizona, is withdrawing approximately 4,570 units that were distributed nationwide.

The recall was initiated due to lack of assurance of sterility. The manufacturer lacks adequate validation data for decontamination cycles, which are essential to ensure the product's sterility.

Affected lots include multiple batch numbers with expiration dates ranging from July 16, 2023 through September 7, 2023 (NDC: 72196-7019-1).

Healthcare providers who have received these IV bags should not use them and should remove them from inventory. Healthcare providers or patients who believe they have been exposed to this product should consult their healthcare provider. Adverse events should be reported to the FDA's MedWatch program.

The recalled product

Product: EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7019-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable medication
Hazard: sterility-failure
contamination
Affected units: 4,570

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: 36-240224
Exp. 7/16/2023
36-242322
EXP. 7/24/2023
36-242445
Exp. 7/25/2023
36-243305
Exp. 7/27/2023
36-243813
Exp. 7/31/2023
36-246166
36-246167
Exp. 8/3/2023
36-247670
Exp. 8/9/2023
36-248992
Exp.8/16/2023
36-249468
Exp. 8/17/2023
36-249590

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 95 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 95 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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