Agency classClass IIOur severity:Severe FDA (Drugs)·D-1034-2017·Announced 2017-08-02

SCA Pharmaceuticals Recalls Fentanyl and Ropivacaine Infusion Bags

SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential for serious adverse health consequences such as loss of sterility in an injectable product.

Plain-English summary

SCA Pharmaceuticals is recalling fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, NDC# 70004-0260-40. The recall is limited to Lot 20170509@17 with a best-use date of 8/7/2017. The product was distributed nationwide.

The recall was initiated because the product has a lack of assurance of sterility and has the potential to leak. This is an FDA Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should discontinue use of the affected product. Consumers should check their medication for the specific lot number and best-use date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or healthcare provider for disposal or replacement.

The recalled product

Product: fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40
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 (1)

Lots: 20170509@17 BUD: 8/7/2017

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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