Multi-event November 2018 FDA Recall Nitrofurantoin
monohydrate/macrocrystals by Sandoz Inc

This Multi-event Class II drug recall was voluntarily initiated by Sandoz Inc on November 2, 2018 for the product Nitrofurantoin (monohydrate/macrocrystals). The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0261-2019 TERMINATED D-0259-2019 TERMINATED D-0260-2019 TERMINATED D-0262-2019 TERMINATED D-0258-2019 TERMINATED D-0257-2019 TERMINATED

Recall Number: D-0261-2019

Reason for Recall
Cross Contamination with Other Products
Initiated
11-02-2018
Reported
11-21-2018
Quantity
1550 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81457
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-02-2020
Product Description About Product Description
Full technical description of the product.
Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00

Batch or Lot Expiration Information

Lot# : JA9534, Exp. 05/2021

Recall Number: D-0259-2019

Reason for Recall
Cross Contamination with Other Products
Initiated
11-02-2018
Reported
11-21-2018
Quantity
7817 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81457
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-02-2020
Product Description About Product Description
Full technical description of the product.
Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00

Batch or Lot Expiration Information

Lot# : HZ7896, Exp. 05/2021

Recall Number: D-0260-2019

Reason for Recall
Cross Contamination with Other Products
Initiated
11-02-2018
Reported
11-21-2018
Quantity
5100 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81457
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-02-2020
Product Description About Product Description
Full technical description of the product.
Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00

Batch or Lot Expiration Information

Lot# : JA3077, Exp. 05/2021

Recall Number: D-0262-2019

Reason for Recall
Cross Contamination with Other Products
Initiated
11-02-2018
Reported
11-21-2018
Quantity
23053 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81457
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-02-2020
Product Description About Product Description
Full technical description of the product.
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01

Batch or Lot Expiration Information

Lot# : JA7319, JA 7320, JA7321, Exp. 03/2020

Recall Number: D-0258-2019

Reason for Recall
Cross Contamination with Other Products
Initiated
11-02-2018
Reported
11-21-2018
Quantity
18,832 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81457
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-02-2020
Product Description About Product Description
Full technical description of the product.
Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01

Batch or Lot Expiration Information

Lot# Lots: a) JA9535 Exp. 05/2021.

Affected Packages Involved in this Recall

0781-1635-10 Isosorbide Dinitrate
0781-1635-01 Isosorbide Dinitrate
0781-1635-13 Isosorbide Dinitrate
0781-1556-01 Isosorbide Dinitrate
0781-1556-05 Isosorbide Dinitrate
0781-1556-10 Isosorbide Dinitrate
0781-1556-13 Isosorbide Dinitrate
0781-1695-13 Isosorbide Dinitrate
0781-1695-10 Isosorbide Dinitrate
0781-1695-01 Isosorbide Dinitrate

Recall Number: D-0257-2019

Reason for Recall
Cross Contamination with Other Products
Initiated
11-02-2018
Reported
11-21-2018
Quantity
14366 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81457
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-02-2020
Product Description About Product Description
Full technical description of the product.
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540

Batch or Lot Expiration Information

Lot# Lots: a) JB4952, JA7322 Exp. 03/2020; b) JA7324, Exp.03/2020

Affected Packages Involved in this Recall

0185-0122-01 Nitrofurantoin (monohydrate/macrocrystals)
0185-0122-10 Nitrofurantoin (monohydrate/macrocrystals)