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.
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 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
- 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
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