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Teva North America Recall: ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 m

Teva North America Recall: ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 m is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Teva North America; Product: ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARM

Recalling firmTeva North America
ProductARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).
Reason for recallCGMP Deviations
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionNationwide and Puerto Rico
Recall initiated20160617
Recall numberD-1494-2016
Categorydrug
StatePA
CountryUnited States

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