Sagent Pharmaceuticals Recalls Atracurium Besylate Injection Due to Sterility Concerns
Sagent Pharmaceuticals is recalling Atracurium Besylate Injection vials because FDA observations regarding aseptic and GMP practices at the manufacturing site may have impacted product sterility.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant risks such as sterility failures in injectable drugs are classified as Severe (Score 4).
Plain-English summary
Sagent Pharmaceuticals Inc is recalling 140,720 vials of Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL). The affected product is a 5 mL single-dose vial intended for intravenous injection, manufactured for Sagent Pharmaceuticals in Schaumburg, IL. The specific lots involved are VATA012 (Exp 11/15) and VATA015 (Exp 08/16).
The recall was initiated due to FDA observations pertaining to aseptic and Good Manufacturing Practice (GMP) practices at the manufacturer's site. These observations potentially impact the sterility of the product. The agency classification for this recall is Class II.
The product was distributed nationwide and in Puerto Rico. Healthcare providers and facilities should discontinue use of the affected lots and contact the recalling firm for further instructions.
The recalled product
- Product
- Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
- Manufacturer
- Sagent Pharmaceuticals Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 140,720
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 (4)
- Lot Numbers: VATA012
- Exp 11/15
- VATA015
- Exp 08/16
Distribution
Part of a larger recall action
This product is one of 2 recalled by Sagent Pharmaceuticals Inc 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 2 products in this recall →Related recalls
Same manufacturer · Sagent Pharmaceuticals Inc
See all →- HighNafcillin for Injection recalled nationwide for lack of sterility assurance
FDA (Drugs) · 2023-05-31
- HighNafcillin for Injection Recalled Nationwide for Lack of Sterility Assurance
FDA (Drugs) · 2023-05-31
- HighNafcillin Injectable Medication Recalled for Sterility Assurance Failure
FDA (Drugs) · 2023-05-31
- ModerateHeparin Sodium Injection Recalled Due to Labeling Issue
FDA (Drugs) · 2023-03-15
- SevereSagent Recalls Phenylephrine Hydrochloride Injection Due to Sterility Concerns
FDA (Drugs) · 2021-03-24
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29