FDA-Drug2017-02-08Class III

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

Hetero Drugs Ltd. - Unit 1
Hazard

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

Sold states
NJ only.
Affected count
20,412 units
Manufactured in
Plot Nos. 213, 214, 255, Bonthapally Village, Jinnaram Mandal, Medak District, N/A, India
Products
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

Official notice

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

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