The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1358-2015·Announced 2015-09-02

PharMEDium Recalls Epinephrine Injection Bags Due to Particulate Matter

PharMEDium Services, LLC is recalling 264 bags of Epinephrine HCl injection due to the presence of particulate matter in the saline solution.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I', which corresponds to a Critical severity score of 5 according to the rubric.

Plain-English summary

PharMEDium Services, LLC is recalling 264 bags of EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP. The recall was initiated because the products were produced using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP that were subsequently recalled by the manufacturer due to the presence of particulate matter.

The affected products are packaged in 250 mL bags and are prescription-only. The specific lot numbers involved are 15033030S and 15033031S with an expiration date of 04/26/15, and 15026051S with an expiration date of 05/03/15. The distribution pattern for these products was nationwide.

Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected products immediately. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

Product
EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6119, NDC# 61553-119-61.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injection
Hazard
Affected units
264

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 (5)

  • Lot #: 15033030S
  • 15033031S
  • Exp 04/26/15
  • 15026051S
  • Exp 05/03/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Pharmedium Services, LLC 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 6 products in this recall →

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