Teva Norepinephrine Bitartrate Injection Recalled for Sterility Assurance
Teva Pharmaceuticals USA is recalling Norepinephrine Bitartrate Injection, USP 4 mg/4 mL vials due to lack of assurance of sterility. The product was distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall of an injectable drug where sterility cannot be assured. Norepinephrine is a critical care medication, and loss of sterility assurance in injectable products poses serious risk of infection and patient harm, meeting the rubric criterion for FDA Class II with significant risk of serious injury.
Plain-English summary
Teva Pharmaceuticals USA is recalling Norepinephrine Bitartrate Injection, USP 4 mg/4 mL in 4 mL single dose vials packaged in 10 vial cartons. The recall affects 34,100 vials distributed nationwide, including Puerto Rico.
The recall is due to lack of assurance of sterility. The affected lots are: Lot #31329045B (expiration 07/2021), Lot #31329077B (expiration 08/2021), and Lot #31329312B (expiration 09/2021). The vial NDC is 0703-1153-01 and the carton NDC is 0703-1153-03.
Patients using this product should contact their healthcare provider or pharmacist. Healthcare providers and patients who have dispensed or used affected vials should contact Teva Pharmaceuticals USA for further guidance.
The recalled product
- Product
- Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01
- Manufacturer
- Teva Pharmaceuticals USA
- Hazard
- sterility-assurance
- infection-risk
- injectable-contamination
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 #: 31329045B
- exp. date 07/2021
- 31329077B
- exp. date 08/2021
- 31329312B
- exp. date 09/2021
Distribution
Distributed nationwide across the United States.
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