Key Takeaway

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 - 50 by Hetero Drugs Ltd. - Unit 1 was recalled on December 29, 2016. The hazard: Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.

FDA Drug Class III Terminated

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 - 50

Recalled: December 29, 2016 ~20,412 units units affected D-0453-2017

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

Hazard / Reason

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

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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 - 50

Drugs

Company Information

Hetero Drugs Ltd. - Unit 1

Medak District, N/A, India

View all 1 recalls by Hetero Drugs Ltd. - Unit 1 →

Distribution

NJ only.

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Frequently Asked Questions

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