The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0829-2022·Announced 2022-05-11

Norepinephrine Injection Recalled Nationwide for Manufacturing Quality Deviations

SCA Pharmaceuticals recalled 120 bags of Norepinephrine 8mg injection nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall was initiated April 25, 2022.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II voluntary recall with no reported illnesses, injuries, or deaths. The CGMP deviations represent a manufacturing quality issue but no specific harm has been documented, making this a precautionary recall consistent with Moderate severity.

Plain-English summary

SCA Pharmaceuticals has recalled 120 bags of Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL injection, Lot #1222035815 (expiration July 10, 2022). This is a prescription medication.

The recall was initiated due to deviations from Current Good Manufacturing Practice (CGMP) standards in the drug's manufacturing process. SCA Pharmaceuticals voluntarily initiated the recall on April 25, 2022. The FDA classified this as a Class II recall on May 2, 2022.

The product was distributed nationwide within the United States. Healthcare providers who received this lot should take immediate action.

Healthcare providers should not use the recalled lot. The recall was terminated on September 9, 2022.

The recalled product

Product
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40
Manufacturer
SCA Pharmaceuticals
Category
Drug
Hazard
Affected units
120

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)

  • Lot #: 1222035815
  • Exp. Date 10-Jul-22

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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