CLASS II Drug recall · Reported 11 Mar 2015 · FDA Enforcement Report
Atracurium Besylate Injection, USP, 100 mg per (10 mg per mL) recalled
Sagent Pharmaceuticals is recalling Atracurium Besylate Injection, USP, 100 mg per (10 mg per mL), distributed nationwide in the US. The recall was initiated on 23 Feb 2015 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-0399-2015
- FDA event ID
- 70600
- Recalling firm
- Sagent Pharmaceuticals, Schaumburg, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2015
- FDA classified
- 3 Mar 2015
- Reported
- 11 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Feb 2015 | Recall initiated by company | |
| 3 Mar 2015 | Classified by FDA | +8 days |
| 11 Mar 2015 | Published in enforcement report | +8 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: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
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
Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Which lots are affected?
Lot Numbers: VATB012, VATB013, VATB014, Exp 11/15; VATB017, Exp 08/16
Where was it sold?
Nationwide 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 70600| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Atracurium Besylate Injection, USP, 50 mg per (10 mg per mL) recalled | Sagent Pharmaceuticals | Sterility | Nationwide |
More recalls from Sagent Pharmaceuticals
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Busulfan Injection, 60 mg per (6 mg per mL), mL Single-Dose Vials recalledBusulfan | Sagent Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Docetaxel Injection, USP, 80 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS I | Docetaxel Injection, USP, 160 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Oxacillin for Injection, USP per pharmacy, For Intravenous Use recalled | Sagent Pharmaceuticals | Sterility | Nationwide |
Other Atracurium recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Atracurium Besylate Injection, USP, 50 mg per (10 mg per mL) recalled | Sagent Pharmaceuticals | Sterility | Nationwide |