Multi-event December 2016 FDA Recall Drug by Apotex Corp.

This Multi-event Class II drug recall was voluntarily initiated by Apotex Corp. on December 14, 2016 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in United States and the recall is currently terminated.

Reported Recall Events

D-0244-2017 TERMINATED D-0245-2017 TERMINATED

Recall Number: D-0244-2017

Reason for Recall
CGMP Deviations
Initiated
12-14-2016
Reported
01-11-2017
Quantity
35,819 bottles (358,190,000 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75964
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.
Apotex Corp.
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.
United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-15-2022
Product Description About Product Description
Full technical description of the product.
Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01

Batch or Lot Expiration Information

Lot# : KT5981, KT5982, KT5983; Exp. Date 01/17.

Recall Number: D-0245-2017

Reason for Recall
CGMP Deviations
Initiated
12-14-2016
Reported
01-11-2017
Quantity
13,179 bottles (1,317,900 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75964
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.
Apotex Corp.
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.
United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-15-2022
Product Description About Product Description
Full technical description of the product.
Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01

Batch or Lot Expiration Information

Lot# : KW8378; Exp. Date 05/17.