Drug Injection Recall: Norepinephrine Bitartrate Impurity Above Specification
Sun Pharmaceutical is recalling Norepinephrine Bitartrate Injection due to a chemical impurity exceeding specification limits detected during routine monitoring. The recall affects 16,450 vials distributed nationwide.
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: This is an FDA Class III recall with no reported illnesses or injuries. The impurity above specification limits represents low-risk contamination requiring precautionary action. Per the rubric, FDA Class III recalls are typically scored 1 or 2; the specification failure warrants Moderate (2) rather than Low (1).
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Norepinephrine Bitartrate Injection, USP (1 mg/mL) manufactured by Gland Pharma Limited. The recall affects 16,450 vials with lot numbers G1510001 (expiration 11/2023), G151002 (expiration 12/2023), and G151003 (expiration 02/2024), distributed nationwide.
The recall was initiated because routine product monitoring detected norepinephrine sulfonic acid impurity above specification limits. Norepinephrine Bitartrate Injection is an intravenous drug used in critical care settings to manage blood pressure.
Healthcare providers should not use the affected lots. Distributors and healthcare facilities that have received these lots should remove them from use and contact Sun Pharmaceutical for return instructions.
No illnesses or injuries have been reported in connection with this recall. The FDA classified this as a Class III recall.
The recalled product
- Product
- NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE BITARTRATE)
- Brand
- NOREPINEPHRINE BITARTRATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Intravenous Injection
- Hazard
- impurity
- specification-failure
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 (6)
- Lot Number: G1510001
- Exp 11/2023
- G151002
- Exp. 12/2023
- and G151003
- Exp 02/2024
Distribution
Distributed nationwide across the United States.
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