# FDA recall D-1364-2020

> **Preferred Pharmaceuticals, Inc.** · Class II · drug recall initiated 2020-06-17.

## Product

Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01

## Reason for recall

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

## Distribution

Product was distributed to two medical clinics located in FL.

## Key facts

- **Recall number:** D-1364-2020
- **Recalling firm:** Preferred Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-06-17
- **Report date:** 2020-07-08
- **Termination date:** 2024-03-21

- **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-1364-2020

## Citation

> AI Analytics. FDA recall D-1364-2020. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-1364-2020. Source: US FDA. Licensed CC0.

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