September 2018 FDA Recall Fenofibrate by Hetero Labs, Ltd. - Unit Iii
D-1211-2018 - Presence of Foreign Tablet/Capsule
This Class III drug recall was voluntarily initiated by Hetero Labs, Ltd. - Unit Iii on September 12, 2018 for the product Fenofibrate. The FDA reported the reason for recall as presence of foreign tablet/capsule. The product was distributed in Indiana and Louisiana and the recall is currently terminated.
Recall Number: D-1211-2018
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
09-12-2018
10-03-2018
5,424 bottles
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.
Hetero Labs, Ltd. - Unit III
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.
Indiana and Louisiana
11-29-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90
Batch or Lot Expiration Information
Lot# : E181370, Exp. 5/2020
