Agency classClass IIOur severity:Severe FDA (Drugs)·D-1005-2017·Announced 2017-08-02

SCA Pharmaceuticals Recalls Bupivacaine HCl Due to Sterility Concerns

SCA Pharmaceuticals is recalling Bupivacaine HCl 0.1% 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance for an injectable drug represents a significant risk of harm, aligning with the Severe criteria for Class II recalls with potential for serious adverse health consequences.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling Bupivacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free. 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 identified by NDC# 70004-0060-40. Specific lots involved in the recall include 20170429@33 with a best-use date of 7/28/2017, and 20170503@23 with a best-use date of 8/1/2017. The distribution pattern for this product is nationwide.

Healthcare providers and patients should discontinue use of the affected lots and contact SCA Pharmaceuticals or their supplier 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: BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0060-40
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable Anesthetic
Hazard: lack-of-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: 20170429@33 BUD: 7/28/2017
20170503@23 BUD: 8/1/2017

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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