Multi-event January 2017 FDA Recall Fluconazole by The Harvard Drug Group
This Multi-event Class II drug recall was voluntarily initiated by The Harvard Drug Group on January 5, 2017 for the product Fluconazole. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0689-2017
Failed Dissolution Specifications
01-05-2017
05-10-2017
914 cartons
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.
The Harvard Drug Group
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 within the US
08-04-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61
Batch or Lot Expiration Information
Lot# :T-00519, Exp. 01-17
Affected Packages Involved in this Recall
Recall Number: D-0688-2017
Failed Dissolution Specifications
01-05-2017
05-10-2017
2,341 cartons
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.
The Harvard Drug Group
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 within the US
08-04-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61
Batch or Lot Expiration Information
Lot# : T-00520, EXP 02-17, T-00632, T-00699, EXP. 04-17
