The Recall Desk
ModerateFDA (Drugs)·D-0029-2017·Announced 2016-10-19

Pharmedium Recalls Ephedrine Sulfate Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 995 syringes of ePHEDrine Sulfate because stability data does not support the expiration dates, posing a risk of loss of potency.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) as it involves a risk of temporary or medically reversible adverse health consequences, such as loss of potency, without reports of serious injury or death.

Plain-English summary

Pharmedium Services, LLC is recalling 995 syringes of ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, Product code 2R3301. The recall is being conducted because stability data does not support the expiration dates for the product, which may result in a potential loss of potency in the drugs packaged and stored in syringes.

The affected product is distributed nationwide. The recall includes Lot Numbers 15112081M and 15113016M, with expiration dates between 07/15/15 and 10/12/15. The product is a prescription-only medication intended for intravenous use.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative 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, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3301.
Manufacturer
Pharmedium Services, LLC
Category
Drug — IV Solution
Hazard
Affected units
995

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 (3)

  • Lot Numbers: 15112081M
  • 15113016M
  • Exp between 07/15/15-10/12/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 69 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 69 products in this recall →

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