The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1088-2020·Announced 2020-04-15

PharMEDium Recalls ePHEDrine Sulfate IV Syringes Due to Sterility Concerns

PharMEDium Services is recalling 375 units of ePHEDrine Sulfate IV syringes because of a lack of sterility assurance.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. According to the rubric, an FDA Class II recall involving a risk of harm (lack of sterility assurance in an IV product) where injury has not yet been reported falls under the 'Severe' category (Score 4), specifically aligning with the criterion for significant injury/property-damage reports or high-risk scenarios not yet resulting in reported illness but classified as Class II.

Plain-English summary

PharMEDium Services, LLC is recalling 375 units of ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringes. The product is intended for intravenous use and is preservative-free. The recall is being conducted because of a lack of sterility assurance.

The affected product is identified by NDC 71030-003-09, lot code 193500012D, and an expiration date of 3/16/2020. The recall notice indicates that the firm is recalling 46 lots of various products for this reason, though the specific distribution details for this particular ePHEDrine Sulfate lot are limited to the 375 units listed in the structured data.

Healthcare providers and patients should stop using the affected product and contact the manufacturer or their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09
Manufacturer
PharMEDium Services, LLC
Category
Drug — IV Infusion
Hazard
Affected units
375

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 (2)

  • 193500012D
  • Exp 3/16/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 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 13 products in this recall →

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