Multi-event January 2016 FDA Recall Drug by Apotex Scientific, Inc

This Multi-event Class III drug recall was voluntarily initiated by Apotex Scientific, Inc on January 26, 2016 for the product Drug. The FDA reported the reason for recall as failed dissolution specification. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1435-2016 TERMINATED D-1436-2016 TERMINATED D-1437-2016 TERMINATED

Recall Number: D-1435-2016

Reason for Recall
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Initiated
01-26-2016
Reported
07-20-2016
Quantity
107,880 (60 ct bottle)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73419
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.
Apotex Scientific, 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, Alaska, Hawaii, and Puerto Rico.
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.
Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;

Batch or Lot Expiration Information

Lot# : KV9795, KV9794, KV9796, KX6278; Exp 04/30/2016.

Recall Number: D-1436-2016

Reason for Recall
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Initiated
01-26-2016
Reported
07-20-2016
Quantity
605,989 (30 ct) bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73419
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.
Apotex Scientific, 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, Alaska, Hawaii, and Puerto Rico.
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.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;

Batch or Lot Expiration Information

Lot# : KW2167,KY9960, KV9789, KV9788; Exp 02/29/2016
Lot# : KY9961, Exp 04/30/2016
Lot# : KX6311, KX6312, KY7795, KX6315, Exp 05/31/2016
Lot# : KX6317, Exp 06/30/2016.

Recall Number: D-1437-2016

Reason for Recall
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Initiated
01-26-2016
Reported
07-20-2016
Quantity
750,273 (30 ct) bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73419
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.
Apotex Scientific, 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, Alaska, Hawaii, and Puerto Rico.
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.
Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.

Batch or Lot Expiration Information

Lot# : KY5120, KW2164, KY9953, KV9791, KV9792, Exp 03/31/2016.