# FDA recall D-0601-2018

> **Hetero Labs Limited Unit V** · Class II · drug recall initiated 2018-02-13.

## Product

Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only,   Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60

## Reason for recall

Temperature Abuse: Valganciclovir Tablets USP 450 mg and  Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).

## Distribution

NJ and then distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0601-2018
- **Recalling firm:** Hetero Labs Limited Unit V
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-02-13
- **Report date:** 2018-03-21
- **Termination date:** 2021-02-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jadcherla Mandal, Mahaboob Nagar, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0601-2018

## Citation

> AI Analytics. FDA recall D-0601-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-0601-2018. Source: US FDA. Licensed CC0.

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