December 2016 FDA Recall Drug by The Harvard Drug Group (D-0692-2017 - Superpotent Drug; out of specification results for assay (manufacturer))
This Class III drug recall was voluntarily initiated by The Harvard Drug Group on December 27, 2016 for the product Drug. The FDA reported the reason for recall as superpotent drug; out of specification results for assay (manufacturer). The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0692-2017
Superpotent Drug; out of specification results for assay (manufacturer)
12-27-2016
05-10-2017
36,990 tablets
Recall Profile & Regulatory Data
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.
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 and PR
07-27-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04
Batch or Lot Expiration Information
Lot# LOT: T-00601 Exp: 04-2017
