Reported Jun 8, 2022 · Terminated
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin…
Direct Rx
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Direct Rx · 94 Worldwide Dr · Dawsonville, GA · 30534-6828
Is this the product you have?
- Losartan Pot./HCTZ 100/12.5
- mg Packaged and Distributed ByDirect Rx Dawsonville
- GA 30534 Mfg ForLupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 Lot: 11MY2103 Exp. 11/30/22 2 Lot: 05JA2106 Exp. 6/30/22 b) 90-count bottles 3 Lot: 20MY2115 Exp. 11/30/22 4 Lot: 22JU2118 Exp. 12/31/22 5 Lot: 29JY2113 Exp. 12/31/22 6 Lot: 13SE2113 Exp. 2/28/23 7 Lot: 05JA2106 Exp. 6/30/22 - Amount recalled
- 81 bottles
Where it was sold
Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
This product could cause temporary or reversible health problems — stop using it.
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