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.
What this means for you
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 →Related recalls
Same manufacturer · SCA Pharmaceuticals
See all →- HighSCA Pharmaceuticals Fentanyl-Bupivacaine Injectable Recall Due to Manufacturing Deviations
FDA (Drugs) · 2023-08-02
- ModerateFDA recalls Oxytocin product for low potency nationwide
FDA (Drugs) · 2023-05-03
- ModerateFentanyl Injection Syringes Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2023-03-08
- ModerateDrug recall: Vancomycin HCl injection bags for manufacturing deviations
FDA (Drugs) · 2022-05-11
- ModerateDrug recall: fentanyl and bupivacaine injectable solution manufacturing deviations
FDA (Drugs) · 2022-05-11
Same hazard · manufacturing deviation
See all →- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Vancomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateSynjardy XR Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2026-07-08
- ModerateDuloxetine delayed-release capsules recalled for N-nitroso impurity contamination
FDA (Drugs) · 2026-05-13
- ModerateFentanyl Citrate Injectable Solution Recalled for cGMP Deviations
FDA (Drugs) · 2026-05-06