# FDA recall D-0385-2021

> **Preferred Pharmaceuticals, Inc.** · Class II · drug recall initiated 2021-04-28.

## Product

Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1

## Reason for recall

CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.

## Distribution

Distributed to two physician consignees located in FL.

## Key facts

- **Recall number:** D-0385-2021
- **Recalling firm:** Preferred Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2021-04-28
- **Report date:** 2021-05-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Anaheim, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0385-2021

## Citation

> AI Analytics. FDA recall D-0385-2021. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0385-2021. Source: US FDA. Licensed CC0.

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