# FDA recall D-406-2014

> **Betachem, Inc.** · Class II · drug recall initiated 2013-10-07.

## Product

Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27 M.I.D.C., Chincholi, Taq.: Mohol, Solapur-413 255. Maharashtra, India; NDC No. 10828-002-06, Cas No: 1115-70-4

## Reason for recall

CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.

## Distribution

MO

## Key facts

- **Recall number:** D-406-2014
- **Recalling firm:** Betachem, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-10-07
- **Report date:** 2014-01-22
- **Termination date:** 2017-08-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Upper Saddle River, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-406-2014

## Citation

> AI Analytics. FDA recall D-406-2014. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-406-2014. Source: US FDA. Licensed CC0.

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