Multi-event June 2019 FDA Recall Drug by Golden State Medical Supply Inc.

This Multi-event Class II drug recall was voluntarily initiated by Golden State Medical Supply Inc. on June 14, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1463-2019 TERMINATED D-1464-2019 TERMINATED D-1465-2019 TERMINATED D-1462-2019 TERMINATED

Recall Number: D-1463-2019

Reason for Recall
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Initiated
06-14-2019
Reported
07-17-2019
Quantity
14,955 bottles (1,345,950 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83161
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.
Golden State Medical Supply Inc.
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
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide One (1) US government account. No foreign accounts.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2020
Product Description About Product Description
Full technical description of the product.
Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90

Batch or Lot Expiration Information

Lot# : GS017651, Expiration 01/2020

Recall Number: D-1464-2019

Reason for Recall
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Initiated
06-14-2019
Reported
07-17-2019
Quantity
1,470 bottles (1,470,000 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83161
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.
Golden State Medical Supply Inc.
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
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide One (1) US government account. No foreign accounts.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2020
Product Description About Product Description
Full technical description of the product.
Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10

Batch or Lot Expiration Information

Lot# : GS017387, Expiration 01/2020

Recall Number: D-1465-2019

Reason for Recall
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Initiated
06-14-2019
Reported
07-17-2019
Quantity
32,835 bottles (2,955,150 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83161
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.
Golden State Medical Supply Inc.
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
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide One (1) US government account. No foreign accounts.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2020
Product Description About Product Description
Full technical description of the product.
Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90

Batch or Lot Expiration Information

Lot# : GS017042, Expiration 01/2020; GS017043, Expiration 01/2020; GS017044, Expiration 01/2020; GS017541, Expiration 01/2020

Recall Number: D-1462-2019

Reason for Recall
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Initiated
06-14-2019
Reported
07-17-2019
Quantity
4,037 bottles (121,110 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83161
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.
Golden State Medical Supply Inc.
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
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide One (1) US government account. No foreign accounts.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2020
Product Description About Product Description
Full technical description of the product.
Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30

Batch or Lot Expiration Information

Lot# : GS017479, Expiration 01/2020