Multi-event December 2019 FDA Recall Drug by Denton Pharma, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Denton Pharma, Inc. on December 20, 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-0794-2020 TERMINATED D-0795-2020 TERMINATED

Recall Number: D-0794-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
12-20-2019
Reported
01-29-2020
Quantity
1,341 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84657
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.
Denton Pharma, 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-05-2023
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.

Batch or Lot Expiration Information

Lot# a). N102851902, Exp. 04/30/2021 b). D102851801, Exp. 04/2021 c). N102851901, Exp. 11/30/2021 N102851903, Exp. 12/31/2021 N102851906, Exp. 03/31/2022 d). N102851904, Exp. 02/28/2022 N102851905, Exp. 12/31/2021 e). C102851901, Exp. 11/30/2021 C102851902, Exp. 11/30/2021 C102851903, Exp. 11/30/2021 C102851904, Exp. 05/31/2021 C102851905, Exp. 02/28/2022 C102851906, Exp. 02/28/2022 C102851907, Exp. 03/31/2022

Recall Number: D-0795-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
12-20-2019
Reported
01-29-2020
Quantity
467 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84657
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.
Denton Pharma, 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-05-2023
Product Description About Product Description
Full technical description of the product.
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131

Batch or Lot Expiration Information

Lot# a). N106851901, Exp. 11/30/2021 N106851902, Exp. 10/31/2021 b). C106851901, Exp. 11/30/2021 C106851902 Exp. 10/31/2021 C106851903 Exp. 02/28/2022 C106851904 Exp. 11/30/2021 C106851905 Exp. 05/31/2022