Agency classClass IIOur severity:Severe FDA (Drugs)·D-1008-2017·Announced 2017-08-02

SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Sterility Concerns

SCA Pharmaceuticals is recalling specific lots of fentanyl injection 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury risks or structural defects in medical products.

Plain-English summary

SCA Pharmaceuticals is recalling fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bags. The affected product is preservative-free and requires a prescription. The recall covers specific lots with expiration dates of July 27, 2017, and August 9, 2017.

The recall was initiated because the product has a lack of assurance of sterility and has the potential to leak. This defect poses a risk to patient safety as the medication is intended for injection.

The recall is distributed nationwide. Healthcare providers and patients should stop using the affected lots and contact SCA Pharmaceuticals or their local FDA office for further instructions.

The recalled product

Product: fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag (Total fentaNYL Dose 1250 mcg/ 250 mL), Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0201-40
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injection
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 (3)

Lots: 20170428@57 BUD: 7/27/2017
20170428@58 BUD: 7/27/2017
20170511@24 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 →

Same manufacturer · SCA Pharmaceuticals

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