Agency classClass IIOur severity:High FDA (Drugs)·D-0220-2018·Announced 2018-01-24

Pharmedium Recalls Subpotent Ephedrine Sulfate Syringes Nationwide

Pharmedium Services is recalling 5,002 pre-filled ephedrine sulfate syringes nationwide because the drug was subpotent. The voluntary recall was initiated in October 2017.

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 3/5 (High).

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: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a subpotent drug, which is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Pharmedium Services, LLC has voluntarily recalled 5,002 pre-filled syringes of ePHEDrine Sulfate In 0.9% Sodium Chloride. The product is packaged in 5-count and 25-count cartons and is available by prescription only. The recall covers specific lots with expiration dates ranging from January 10, 2018, to January 21, 2018.

The reason for the recall is that the drug was found to be subpotent, meaning it did not contain the full labeled amount of the active ingredient. The recall was initiated on October 30, 2017, and was classified as Class II by the FDA. The affected products were distributed nationwide within the United States.

Consumers and healthcare providers should stop using the affected syringes and contact Pharmedium Services or their healthcare provider for further instructions. The recall status is currently terminated.

The recalled product

Product: ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count cartons, NDC 71030-0003-10 and NDC 71030-0003-20, and b) 25-count cartons, NDC 71030-0003-21 and NDC 71030-0003-12, Rx Only, PharMEDium…
Manufacturer: Pharmedium Services, LLC
Category: Drug — Injectable
Hazard: subpotent-drug
Affected units: 5,002

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 (14)

Lot #: 172950036M
Exp. 1/21/2018
172940003M
Exp. 1/20/2018
172880044M
Exp. 1/14/2018
172840176M
Exp. 1/11/2018
172920115M
Exp. 1/18/2018
172840015D
Exp. 1/10/2018
172930139M
Exp. 1/19/2018.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Pharmedium Services, LLC

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