Agency classClass IIOur severity:High FDA (Drugs)·D-0701-2023·Announced 2023-05-31

FDA Recalls Epinephrine Injection Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 3,338 bags of epinephrine injectable solution nationwide. The FDA raised concerns about sterility assurance during an inspection.

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: This is an FDA Class II recall of an injectable medication with no reported illnesses or injuries. The hazard—sterility assurance failure—is theoretical risk rather than confirmed contamination. Per the rubric, recalls with no reported illness/injury and theoretical hazards score at most 3 (High).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 3,338 bags of epinephrine in dextrose 5% solution (2 mg/250 mL) due to sterility assurance issues.

The FDA conducted an inspection and determined that sterility could not be assured for these injectable products. Lack of sterility assurance in medications intended to be injected into patients poses a potential risk of contamination and infection.

The affected product was distributed nationwide in the United States. Eight lot numbers are affected, with expiration dates ranging from May 4, 2023 to June 29, 2023.

Healthcare facilities that received this medication should immediately stop using the affected lot numbers and contact the manufacturer for recall instructions.

The recalled product

Product: EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6030-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Compounded Injectable
Hazard: sterility-failure
contamination-risk
Affected units: 3,338

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 (16)

Lot # 37-884448
Exp 05/04/2023
37-887386
Exp 05/16/2023
37-888271
Exp 05/21/2023
37-891189
Exp 05/31/2023
37-893456
Exp 06/11/2023
37-894656
Exp 06/14/2023
37-898333
Exp 06/28/2023
37-898559
Exp 06/29/2023

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 →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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Same hazard · sterility failure