Agency classClass IIOur severity:Severe FDA (Drugs)·D-1018-2017·Announced 2017-08-02

SCA Pharmaceuticals Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling ePHEDrine Sulfate syringes due to a lack of assurance of sterility and potential for leaking.

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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant harm (such as sterility issues in injectable drugs) are categorized as Severe.

Plain-English summary

SCA Pharmaceuticals is recalling ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), prescription only. The recall is due to a lack of assurance of sterility and the potential for the product to leak.

The affected product is identified by NDC# 70004-0600-11. Specific lots involved include 20170503@28 with a best-use date of 7/17/2017, and 20170508@60 with a best-use date of 7/22/2017. The product was distributed nationwide.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0600-11
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable
Hazard: sterility
leakage

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)

Lots: 20170503@28 BUD: 7/17/2017
20170508@60 BUD: 7/22/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 30 recalled by SCA Pharmaceuticals 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 30 products in this recall →

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