Multi-event May 2022 FDA Recall Losartan Potassium And Hydrochlorothiazide by Direct Rx

This Multi-event Class II drug recall was voluntarily initiated by Direct Rx on May 11, 2022 for the product Losartan Potassium And Hydrochlorothiazide. The FDA reported the reason for recall as cgmp deviations- azido impurity levels observed to be above acceptable limits .. The product was distributed in FL and the recall is currently terminated.

Reported Recall Events

D-0895-2022 TERMINATED D-0894-2022 TERMINATED D-0893-2022 TERMINATED

Recall Number: D-0895-2022

Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Initiated
05-11-2022
Reported
06-01-2022
Quantity
11 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90200
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Direct Rx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2022
Product Description About Product Description
Full technical description of the product.
Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

Batch or Lot Expiration Information

Lot# Lots: 08NO2102 Exp. 1/31/25; 17NO2118 Exp. 1/31/25; 18NO2123 Exp. 1/31/25; 25OC2114 Exp. 1/31/25; 22NO2105 Exp. 1/31/25

Affected Packages Involved in this Recall

72189-289-90 Losartan Potassium And Hydrochlorothiazide

Recall Number: D-0894-2022

Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Initiated
05-11-2022
Reported
06-01-2022
Quantity
6 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90200
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Direct Rx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2022
Product Description About Product Description
Full technical description of the product.
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

Batch or Lot Expiration Information

Lot# Lots: 19NO2108 Exp. 1/31/25; 19NO2114 Exp. 1/31/25; 22NO2126 Exp. 1/31/25

Affected Packages Involved in this Recall

72189-297-90 Losartan Potassium And Hydrochlorothiazide

Recall Number: D-0893-2022

Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Initiated
05-11-2022
Reported
06-01-2022
Quantity
11 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90200
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Direct Rx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot: 25OC2116 Exp. 5/31/23

Affected Packages Involved in this Recall

72189-290-90 Losartan Potassium And Hydrochlorothiazide