Agency classClass IIOur severity:High FDA (Drugs)·D-0899-2018·Announced 2018-07-11

SCA Pharmaceuticals Recalls Norepinephrine Bitartrate Bags Due to Sterility Concerns

SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate 8 mg 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterile medication) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

SCA Pharmaceuticals, LLC is conducting a voluntary recall of 1,882 bags of Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL. The recall is being issued due to a lack of assurance of sterility resulting from a potential for leakage in the sterile admixtures.

The affected product was distributed throughout the United States. The recall covers specific lots with expiration dates ranging from 06/18/2018 to 07/11/2018. The specific lot numbers involved are 1218000930, 1218000946, 1218001058, 1218001077, 1218001169, 1218001170, 1218001190, 1218001191, 1218001206, and 1218001317.

Healthcare providers and facilities should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be quarantined and not used. Consumers should contact their healthcare provider if they have questions regarding the use of this medication.

The recalled product

Product: Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Manufacturer: SCA Pharmaceuticals, LLC
Category: Drug — Sterile Admixture
Hazard: sterility
leakage
Affected units: 1,882

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 (11)

Lot # 1218000930
1218000946
1218001058
1218001077
1218001169
1218001170
1218001190
1218001191
1218001206
1218001317
Exp 06/18/2018-07/11/2018

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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