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.
Reported: June 26, 2013 Initiated: June 7, 2013 #D-605-2013
Product Description
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.
Reason for Recall
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
Details
- Recalling Firm
- Sagent Pharmaceuticals Inc
- Units Affected
- 831,950 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Schaumburg, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sagent Pharmaceuticals Inc. Units affected: 831,950 vials.
Why was this product recalled? ▼
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 26, 2013. Severity: Moderate. Recall number: D-605-2013.
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