Agency classClass IIOur severity:Severe FDA (Drugs)·D-0399-2015·Announced 2015-03-11

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard: sterility
infection
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Same manufacturer · Sagent Pharmaceuticals Inc

See all →

High
Nafcillin for Injection recalled nationwide for lack of sterility assurance
FDA (Drugs) · 2023-05-31
High
Nafcillin for Injection Recalled Nationwide for Lack of Sterility Assurance
FDA (Drugs) · 2023-05-31
High
Nafcillin Injectable Medication Recalled for Sterility Assurance Failure
FDA (Drugs) · 2023-05-31
Moderate
Heparin Sodium Injection Recalled Due to Labeling Issue
FDA (Drugs) · 2023-03-15
Severe
Sagent Recalls Phenylephrine Hydrochloride Injection Due to Sterility Concerns
FDA (Drugs) · 2021-03-24

Same hazard · sterility