July 2017 FDA Recall Entecavir by Hetero Usa Inc
D-1095-2017 - Failed Impurities/Degradation Specification
This Class II drug recall was voluntarily initiated by Hetero Usa Inc on July 20, 2017 for the product Entecavir. The FDA reported the reason for recall as failed impurities/degradation specification. The product was distributed in NJ and the recall is currently terminated.
Recall Number: D-1095-2017
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
07-20-2017
08-23-2017
5664 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.
Hetero USA 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.
NJ
02-27-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30
Batch or Lot Expiration Information
Lot# ENT17008, Exp 01/2019
