Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1044-2018·Announced 2018-08-15

PharMEDium Recalls Ephedrine Sulfate Syringes Due to CGMP Deviations

PharMEDium Services is recalling 450 syringes of Ephedrine Sulfate because the product was released while a hood certification discrepancy was under investigation.

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 2/5 (Moderate).

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 indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a manufacturing deviation (CGMP) rather than a confirmed contamination or defect causing harm.

Plain-English summary

PharMEDium Services, LLC is recalling 450 syringes of 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride. The product is identified by Lot 181730039D and has an expiration date of 09/20/2018. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations.

The recall is necessary because the product was released while a hood certification discrepancy was being investigated. This deviation from standard manufacturing protocols may affect the quality or safety of the medication.

The affected product was distributed throughout the United States. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be discontinued and returned to the supplier or disposed of according to local regulations.

The recalled product

Product: 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
Manufacturer: PharMEDium Services, LLC
Category: Drug — Injectable Medication
Hazard: cgmp-deviation
quality-control
Affected units: 450

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)

Lot 181730039D
Exp 09/20/2018

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · PharMEDium Services, LLC

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Same hazard · cgmp deviation