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Sagent Initiates Recall

Shifts production in-house after US FDA concerns about CMO Emcure

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Sagent Pharmaceuticals has recalled two lots of Atracurium Besylate 50mg/5mL single-dose vials and four lots of Atracurium Besylate, 100mg/10mL multi-dose vials. The muscle relaxant injectable is manufactured by CMO Emcure Pharmaceuticals and distributed by Sagent.

Sagent said the recall was prompted by FDA observations pertaining to aseptic and GMP practices at the Emcure’s site potentially impacting product sterility.

Non-sterility of a drug administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.

Sagent has transferred the manufacture of this product to its own facility and this product manufactured at the Sagent facility will not be impacted by the recall.

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