FDA recall D-0453-2017

Product

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

NJ only.

Key facts

Status

Terminated

Initiation date

2016-12-29

Report date

2017-02-08

Termination date

2017-07-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Medak District, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0453-2017