Teva Norepinephrine Bitartrate Injection Recalled for Sterility Assurance
Teva Pharmaceuticals is recalling Norepinephrine Bitartrate Injection USP due to lack of assurance of sterility. The affected lot is distributed in Tennessee, Mississippi, and Ohio.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug. Lack of sterility assurance in injectable medications poses significant risk of serious infection and potential hospitalization. Per the severity rubric, FDA Class II recalls qualify as Severe (score 4).
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL) supplied in 4 mL single-dose vials, 10 vials per carton, due to lack of assurance of sterility. The recalled product has NDC 0703-1153-03, Lot # 100020800, with an expiration date of 07/2022.
The recall affects 11,450 vials that were distributed to customers in Tennessee, Mississippi, and Ohio. The manufacturer has determined that sterility cannot be assured for this lot.
Consumers and healthcare providers in the affected areas who have this product should stop using it. Healthcare professionals should contact their suppliers or Teva Pharmaceuticals for guidance on product replacement and proper handling of the recalled vials.
The recalled product
- Product
- Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.
- Manufacturer
- Teva Pharmaceuticals USA
- Affected units
- 11,450
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 # 100020800
- exp 07/2022
Distribution
Part of a larger recall action
This product is one of 2 recalled by Teva Pharmaceuticals USA 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.
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