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Direct Rx Recall: Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Dist

Direct Rx Recall: Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Dist is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Direct Rx; Product: Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-3

Recalling firmDirect Rx
ProductLosartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
Reason for recallCGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionGA
Recall initiated20190430
Recall numberD-0018-2021
Categorydrug
StateGA
CountryUnited States

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