D-0453-2017 Class III Terminated

Recalled by Hetero Drugs Ltd. - Unit 1 — Medak District, N/A

Recall Details

Product Type
Drugs
Report Date
February 8, 2017
Initiation Date
December 29, 2016
Termination Date
July 11, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20,412 units

Product Description

Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90

Reason for Recall

Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.

Distribution Pattern

NJ only.

Code Information

Lot #: FIN16002, Exp. 03/2018