The Recall Desk
SevereFDA (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.

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: 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
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 →

Related recalls

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · sterility defect

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