Multi-event September 2019 FDA Recall Drug by Sandoz, Inc

This Multi-event Class II drug recall was voluntarily initiated by Sandoz, Inc on September 23, 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-0129-2020 TERMINATED D-0128-2020 TERMINATED D-0127-2020 TERMINATED

Recall Number: D-0129-2020

Reason for Recall
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Initiated
09-23-2019
Reported
10-16-2019
Quantity
136,788 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83875
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.
Sandoz, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-14-2023
Product Description About Product Description
Full technical description of the product.
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31

Batch or Lot Expiration Information

Lot# HD8625 4/30/2020 HD9275 4/30/2020 HU2207 8/31/2020 HX6676 3/31/2021 HX6677 3/31/2021

Recall Number: D-0128-2020

Reason for Recall
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Initiated
09-23-2019
Reported
10-16-2019
Quantity
13,130 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83875
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.
Sandoz, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-14-2023
Product Description About Product Description
Full technical description of the product.
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05

Batch or Lot Expiration Information

Lot# HD1862 4/30/2020 HP9438 9/30/2020 HP9439 9/30/2020 HP9440 9/30/2020

Recall Number: D-0127-2020

Reason for Recall
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Initiated
09-23-2019
Reported
10-16-2019
Quantity
100,314 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83875
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.
Sandoz, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-14-2023
Product Description About Product Description
Full technical description of the product.
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60

Batch or Lot Expiration Information

Lot# HC9266 4/30/2020 HD1865 4/30/2020 HP9441 9/30/2020 JK7994 8/31/2021 JK8659 8/31/2021