The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1014-2017·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 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a sterile medical product with a risk of infection (lack of assurance of sterility) and potential for leakage is categorized as Severe.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling specific lots of fentanyl 2 mcg/mL + bupivacaine 0.1% PF in 0.9% NS 250 mL infusion bags. 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 and was distributed nationwide. The specific lots subject to the recall are 20170502@47 (Best Use Date: 7/31/2017), 20170502@56 (Best Use Date: 7/31/2017), 20170505@26 (Best Use Date: 8/3/2017), and 20170506@25 (Best Use Date: 8/4/2017).

Healthcare providers and patients should stop using the affected lots and contact SCA Pharmaceuticals or their local FDA office for further instructions. The 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
fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0230-40
Manufacturer
SCA Pharmaceuticals
Category
Drug — Infusion Solution
Hazard

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 (4)

  • Lots: 20170502@47 BUD: 7/31/2017
  • 20170502@56 BUD: 7/31/2017
  • 20170505@26 BUD: 8/3/2017
  • 20170506@25 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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