Agency classClass IIOur severity:Severe FDA (Drugs)·D-0898-2018·Announced 2018-07-11

SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns

SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection from non-sterile medical products.

Plain-English summary

SCA Pharmaceuticals, LLC is conducting a voluntary recall of certain lots of Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bags. The recall is being issued due to a lack of assurance of sterility resulting from a potential for leakage in the packaging.

The affected product includes 2,268 bags from specific lots with expiration dates ranging from June 19, 2018, to July 3, 2018. The product was distributed throughout the United States.

Healthcare facilities and consumers should stop using the affected lots immediately and contact SCA Pharmaceuticals or their supplier for instructions on return or disposal.

The recalled product

Product: Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Manufacturer: SCA Pharmaceuticals, LLC
Category: Drug — Sterile Admixtures
Hazard: sterility
leakage
Affected units: 2,268

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 (7)

Lot # 1218000928
1218000944
1218000945
1218001075
1218001076
1218001188
Exp 06/19/2018-07/03/2018

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 12 recalled by SCA Pharmaceuticals, LLC 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 12 products in this recall →

Same manufacturer · SCA Pharmaceuticals, LLC

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