Agency classClass IIOur severity:Severe FDA (Drugs)·D-605-2013·Announced 2013-06-26

Sagent Recalls Vecuronium Bromide Injection Due to Manufacturing Deviations

Sagent Pharmaceuticals is recalling Vecuronium Bromide for Injection because it was not manufactured under current good manufacturing practices, resulting in failed impurity specifications.

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 the rubric specifies that FDA Class II recalls with potential for significant injury or property damage, or those involving structural defects or significant reports, fall under the Severe category. While no specific injuries are reported in the text, the failure of impurity specifications in an IV medication represents a significant risk of harm.

Plain-English summary

Sagent Pharmaceuticals Inc is recalling Vecuronium Bromide for Injection, 10 mg per vial, NDC 25021-657-10. The product is manufactured by MN Pharmaceuticals in Turkey and was distributed nationwide and in Puerto Rico. The recall involves 831,950 vials across multiple lot numbers with expiration dates ranging from July 2013 to May 2014.

The recall was initiated because the product was not manufactured under current good manufacturing practices (CGMP). This deviation contributed to failed impurities and degradation specifications, as a high out-of-specification impurity result was detected during routine quality testing of stability samples.

Healthcare providers and patients should stop using the affected lots of Vecuronium Bromide for Injection and contact Sagent Pharmaceuticals for further instructions or to arrange for the return of the product.

The recalled product

Product: VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.
Manufacturer: Sagent Pharmaceuticals Inc
Category: Drug — Injectable Medication
Hazard: impurity
manufacturing-defect
Affected units: 831,950

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 (20)

Lot #s: 11F23921A
11G24001A
11G24251A
11G24471A
11G24701A
11G25051A
11G25471A
11G24341A
Exp 07/13
11I30521A
11I31651A
11I31661A
11I30481A
11I30721A
11I30731A
Exp 09/13
11I32581A
11K34241A
11K34471A
11K35861A

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Sagent Pharmaceuticals Inc

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Same hazard · impurity