Agency classClass IIOur severity:Severe FDA (Drugs)·D-1015-2017·Announced 2017-08-02

SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Infusion Bags Due to Sterility Concerns

SCA Pharmaceuticals is recalling specific lots of fentanyl and bupivacaine infusion bags because they may leak and lack assurance of sterility.

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, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling fentanyl 2 mcg/mL + bupivacaine 0.125% PF in 0.9% Sodium Chloride 250 mL infusion bags. The recall is due to a lack of assurance of sterility and the potential for the product to leak.

The affected product is prescription-only and was distributed nationwide. The specific lots subject to the recall are 20170503@75 with a beyond-use date of August 1, 2017, and 20170511@21 with a beyond-use date of August 9, 2017.

Healthcare providers and patients should stop using the affected lots and contact SCA Pharmaceuticals or their local FDA office for further instructions on how to return or dispose of the product.

The recalled product

Product: fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0254-40
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable Medication
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@75 BUD: 8/1/2017
20170511@21 BUD: 8/9/2017

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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