Agency classClass IIOur severity:High FDA (Drugs)·D-1073-2023·Announced 2023-08-09

ePHEDrine Injectable Syringes Recalled Over Sterility Assurance Gaps

Central Admixture Pharmacy Services is recalling 8,942 ePHEDrine syringes nationwide due to lack of validation data for sterilization procedures, creating a potential sterility risk for injectable medications.

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 FDA Class II recall lacks reported illnesses or injuries. The hazard—unvalidated sterilization procedures—presents a theoretical risk to product sterility in an injectable medication. Per the severity rubric, risk-of-harm products without reported injury merit a High rating.

Plain-English summary

Central Admixture Pharmacy Services Inc is recalling ePHEDrine in 0.9% sodium chloride injectable syringes (50 mg/5 mL, 10 mg/mL concentration) distributed nationwide. The affected product consists of 8,942 syringes across multiple lot numbers with expiration dates from July 16, 2023 through September 10, 2023.

The recall was initiated because the manufacturer lacks validation data for sanitization cycles used during manufacturing. Without this validation, there is no documented assurance that the sterilization process effectively prevents contamination, creating a potential risk to product sterility.

This is a prescription-only medication distributed nationally. Healthcare facilities, pharmacies, and healthcare providers with this product should discontinue its use and contact the manufacturer or the FDA for guidance on proper handling, quarantine, and return of affected lots.

The recalled product

Product: ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
Manufacturer: Central Admixture Pharmacy Services Inc
Category: Drug — Ephedrine Injectable
Hazard: lack-of-sterility
contamination-risk
Affected units: 8,942

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: 17-270545
Exp. 7/16/2023
17-270614
Exp. 7/17/2023
17-270885
17-270897
Exp. 7/20/2023
17-270980
17-270992
Exp. 7/23/2023
17-271268
Exp. 7/26/2023
17-271338
Exp. 7/27/2023
17-271426
17-271428
Exp. 7/30/2023
17-271691
Exp. 8/2/2023
17-271843

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 39 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 39 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services Inc

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Same hazard · lack of sterility