# FDA recall D-0453-2017

> **Hetero Drugs Ltd. - Unit 1** · Class III · drug recall initiated 2016-12-29.

## 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

- **Recall number:** D-0453-2017
- **Recalling firm:** Hetero Drugs Ltd. - Unit 1
- **Classification:** Class III
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0453-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0453-2017. Source: US FDA. Licensed CC0.

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