Sagent Pharmaceuticals Recalls Atracurium Besylate Injection Due to Sterility Concerns
Sagent Pharmaceuticals is recalling Atracurium Besylate Injection vials because FDA observations suggest potential impacts on 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, which poses a risk of serious injury or death if the product is contaminated.
Plain-English summary
Sagent Pharmaceuticals Inc is recalling 140,850 vials of Atracurium Besylate Injection, USP, 100 mg per 10 mL. The product is a prescription-only medication intended for intravenous injection. The recall covers specific lot numbers VATB012, VATB013, VATB014 (expiring 11/15) and VATB017 (expiring 08/16).
The recall was initiated due to FDA observations regarding aseptic and Good Manufacturing Practice (GMP) practices at the manufacturer's site. These observations potentially impact the sterility of the product. The agency has classified this recall as Class II.
The affected product was distributed nationwide and in Puerto Rico. Healthcare providers and patients should stop using the recalled vials and contact Sagent Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Sagent Pharmaceuticals Inc
- Category
- Drug — Injectable
- Affected units
- 140,850
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 (6)
- Lot Numbers: VATB012
- VATB013
- VATB014
- Exp 11/15
- VATB017
- 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.
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