The Recall Desk
HighFDA (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.

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 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

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.

Related recalls

Same category