Agency classClass IIOur severity:Severe FDA (Drugs)·D-1022-2017·Announced 2017-08-02

SCA Pharmaceuticals Recalls Repinephrine Bitartrate Due to Sterility Concerns

SCA Pharmaceuticals is recalling Repinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL due to a lack of assurance of sterility and potential for product leakage.

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 FDA has classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a medication with sterility and leakage issues is categorized as Severe (Score 4), as it poses a risk of adverse health consequences.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling Repinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock. The recall is being conducted because the product has a lack of assurance of sterility and has the potential to leak.

The affected product is prescription-only (Rx only) and is identified by NDC# 70004-0775-40. The recall includes specific lots with the following details: Lot 20170512@8 with a best use date of 8/10/2017, and Lot 20170506@18 with a best use date of 8/4/2017. The distribution pattern for this recall is nationwide.

Healthcare providers and patients should discontinue use of the affected lots and contact SCA Pharmaceuticals or their supplier for further instructions. The U.S. Food and Drug Administration (FDA) has classified this recall as 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: NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0775-40
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: 20170512@8 BUD: 8/10/2017
20170506@18 BUD: 8/4/2017

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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