Multi-event December 2016 FDA Recall Fluconazole by Dr. Reddy's Laboratories, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on December 28, 2016 for the product Fluconazole. The FDA reported the reason for recall as failed dissolution specifications; 18 month stability time point. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0451-2017
Failed Dissolution Specifications; 18 month stability time point
12-28-2016
02-08-2017
59,440 blister cards
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-19-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12
Batch or Lot Expiration Information
Lot# C500222, C500515, and C500517, exp 12/2016, C502343, exp 03/2017
Affected Packages Involved in this Recall
Recall Number: D-0449-2017
Failed Dissolution Specifications; 18 month stability time point
12-28-2016
02-08-2017
a) 2472 bottles, b) 780 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-19-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Batch or Lot Expiration Information
Lot# a) 30 count C500221, exp 12/2016, C502342, exp 03/2017 b) 100 count C500221, exp 12/2016, C502342, exp 03/2017
Affected Packages Involved in this Recall
Recall Number: D-0452-2017
Failed Dissolution Specifications; 18 month stability time point
12-28-2016
02-08-2017
a) 38,832 and b) 5,064 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-19-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Batch or Lot Expiration Information
Lot# a) 30 count C500228, exp 12/2016, C500848 and C500850, exp 01/2017 C503651 and C503653, exp 04/2017, b) 100 count C500226, exp 12/2016, C500848, C500850, exp 01/2017, C503649 and C503653, exp 04/2017
Affected Packages Involved in this Recall
Recall Number: D-0450-2017
Failed Dissolution Specifications; 18 month stability time point
12-28-2016
02-08-2017
a) 42,984 and b) 7,764 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-19-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Batch or Lot Expiration Information
Lot# a) 30 count C500224, exp 12/2016, C500846, exp 01/2017 b) 100 count C500224, exp 12/2016, exp 12/2016, C501608, exp 02/2017 and C503655, exp 04/2017
