Teva Recalls Vecuronium Bromide Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of Vecuronium Bromide for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in injectables) align with a Severe rating, especially given the risk of infection from non-sterile injectable products.
Plain-English summary
Teva Pharmaceuticals USA is recalling specific lots of Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial. The recall involves approximately 33,6697 vials distributed nationwide in the USA and Puerto Rico. The affected lots are 31325712B, 31326320B, 31326457B, and 31327880B, with expiration dates ranging from 12/2021 to 10/2022.
The recall was initiated because manufacturing areas for these products exceeded acceptance levels for microbial recovery. This condition led to a lack of sterility assurance for these sterile injectable products. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should check their inventory and records for the specific lot numbers and expiration dates listed above. If the product is found, it should be discontinued and returned to the distributor or manufacturer according to standard recall procedures. No specific instructions for immediate patient action are provided in the source text beyond the recall classification.
The recalled product
- Product
- Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable
- Hazard
- Affected units
- 336,697
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 (5)
- Lot # 31325712B
- exp. date 12/2021 31326320B
- exp. date 02/2022 31326457B
- exp. date 02/2022 31327880B
- exp. date 10/2022
Distribution
Part of a larger recall action
This product is one of 15 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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