# FDA recall D-0415-2018

> **Hetero Labs Limited Unit V** · Class II · drug recall initiated 2017-12-22.

## Product

Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30

## Reason for recall

Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0415-2018
- **Recalling firm:** Hetero Labs Limited Unit V
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-12-22
- **Report date:** 2018-02-21
- **Termination date:** 2020-02-05

- **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-0415-2018

## Citation

> AI Analytics. FDA recall D-0415-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0415-2018. Source: US FDA. Licensed CC0.

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