December 2017 FDA Recall Famciclovir by Hetero Labs Limited Unit V
D-0415-2018 - Temperature Abuse
This Class II drug recall was voluntarily initiated by Hetero Labs Limited Unit V on December 22, 2017 for the product Famciclovir. The FDA reported the reason for recall as temperature abuse. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0415-2018
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
12-22-2017
02-21-2018
8,436 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 Labs Limited Unit V
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 in the USA.
02-05-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30
Batch or Lot Expiration Information
Lot# FMC17039, Exp 07/2019.
