Multi-event July 2018 FDA Recall Drug by Nucare Pharmaceuticals Inc

This Multi-event Class II drug recall was voluntarily initiated by Nucare Pharmaceuticals Inc on July 30, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed to three customers in Fl and CA and the recall is currently terminated.

Reported Recall Events

D-1037-2018 TERMINATED D-1038-2018 TERMINATED D-1039-2018 TERMINATED

Recall Number: D-1037-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
07-30-2018
Reported
08-15-2018
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80701
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.
NuCare Pharmaceuticals 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
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.
Distributed to three customers in Fl and CA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2021
Product Description About Product Description
Full technical description of the product.
Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9

Batch or Lot Expiration Information

Lot# U01779; Exp. 04/30/2019

Recall Number: D-1038-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
07-30-2018
Reported
08-15-2018
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80701
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.
NuCare Pharmaceuticals 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
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.
Distributed to three customers in Fl and CA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2021
Product Description About Product Description
Full technical description of the product.
Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,

Batch or Lot Expiration Information

Lot# T11443; Exp. 02/28/2019

Recall Number: D-1039-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
07-30-2018
Reported
08-15-2018
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80701
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.
NuCare Pharmaceuticals 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
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.
Distributed to three customers in Fl and CA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2021
Product Description About Product Description
Full technical description of the product.
Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3

Batch or Lot Expiration Information

Lot# T11577; Exp. 06/30/2019