Drug recall D-0893-2022

Class II Terminated reported Jun 1, 2022

Product

Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

Reason for recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

Lots and codes

Lot: 25OC2116 Exp. 5/31/23

Recall details

Recalling firm
Direct Rx, Dawsonville, GA
Quantity
11 bottles
Distribution
FL
Type
Voluntary: Firm initiated
Recall initiated
May 11, 2022
Terminated
December 2, 2022

Related products