CLASS II Drug recall · Reported 3 Mar 2021 · FDA Enforcement Report
Vecuronium Bromide for Injection, 10 mg recalled
Teva Pharmaceuticals U is recalling Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to Vial (, distributed nationwide in the US. The recall was initiated on 10 Feb 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0279-2021
- FDA event ID
- 87298
- Recalling firm
- Teva Pharmaceuticals U, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Feb 2021
- FDA classified
- 21 Feb 2021
- Reported
- 3 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Feb 2021 | Recall initiated by company | |
| 21 Feb 2021 | Classified by FDA | +11 days |
| 3 Mar 2021 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Product was distributed nationwide in the USA and Puerto Rico.
Questions about this recall
Is Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to Vial ( recalled?
Yes. Teva Pharmaceuticals U recalled Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to Vial ( on 10 Feb 2021. The recall is Class II and its status is Terminated. Recall number D-0279-2021.
Why was it recalled?
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Which lots are affected?
Lot # 31325712B, exp. date 12/2021 31326320B, exp. date 02/2022 31326457B, exp. date 02/2022 31327880B, exp. date 10/2022
Where was it sold?
Product was distributed nationwide in the USA and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Vecuronium bromide recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vecuronium Bromide for Injection 10 mg vial recalled | Teva Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS I | Vecuronium Bromide for Injection 20 mg* *1mg/mL when recalledVecuronium Bromide | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS I | Vecuronium Bromide for Injection 10 mg* recalledVecuronium Bromide | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | Vecuronium bromide for Injection, 10 mg vials recalled | Fresenius Kabi USA | Potency & Assay | Nationwide |