Agency classClass IIOur severity:Severe FDA (Drugs)·D-0735-2021·Announced 2021-08-25

Teva Vecuronium Bromide Injection Recalled for Sterility Assurance

Teva Pharmaceuticals USA is recalling Vecuronium Bromide for Injection 10 mg vials nationwide due to lack of assurance of sterility. The recall affects 62,358 vials distributed across multiple lots.

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 an injectable drug with a sterility assurance defect. Lack of sterility in injectable medications poses serious risk of infection, sepsis, and other life-threatening conditions in patients who receive the product, meeting the criterion for Severe classification.

Plain-English summary

Teva Pharmaceuticals USA is recalling Vecuronium Bromide for Injection 10 mg, 10 mL vials (NDC 0703-2914-01) due to lack of assurance of sterility. A total of 62,358 vials are affected by this recall.

The affected product was distributed nationwide, including Puerto Rico. The recall involves eight lots with expiration dates ranging from December 2021 through May 2023: Lot #31325960B (exp. 12/2021), 31326111B (exp. 01/2022), 31326875B (exp. 03/2022), 31326915B (exp. 03/2022), 31326916B and 31326917B (exp. 04/2022), 31329079B (exp. 04/2023), and 31329085B (exp. 05/2023).

Vecuronium Bromide is a prescription injectable medication. Healthcare providers and patients who have received or currently possess affected vials should contact their local pharmacy or healthcare facility for further guidance.

The recalled product

Product: Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable / Neuromuscular Blocking Agent
Hazard: sterility-defect
injection-safety
Affected units: 62,358

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 (14)

Lot #: 31325960B
exp. date12/2021
31326111B
exp. date 01/2022
31326875B
exp. date 03/2022
31326915B
31326916B
31326917B
exp. date 04/2022
31329079B
exp. date 04/2023
31329085B
exp. date 05/2023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 19 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.

See all 19 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · sterility defect