Agency classClass IIOur severity:Severe FDA (Drugs)·D-0398-2015·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 regarding aseptic and GMP practices at the manufacturing site may have impacted 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 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: sterility
gmp-violation
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

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

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