# FDA recall D-0817-2016

> **Biocon Inc** · Class III · drug recall initiated 2016-03-24.

## Product

Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134

## Reason for recall

Subpotent Drug

## Distribution

PA, CA, & OH

## Key facts

- **Recall number:** D-0817-2016
- **Recalling firm:** Biocon Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-03-24
- **Report date:** 2016-04-20
- **Termination date:** 2017-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Iselin, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0817-2016

## Citation

> AI Analytics. FDA recall D-0817-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0817-2016. Source: US FDA. Licensed CC0.

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