# FDA recall D-807-2013

> **Bayer HealthCare Pharmaceuticals Inc.** · Class III · drug recall initiated 2013-06-13.

## Product

Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin

## Reason for recall

Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.

## Distribution

NY, CA

## Key facts

- **Recall number:** D-807-2013
- **Recalling firm:** Bayer HealthCare Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-13
- **Report date:** 2013-07-24
- **Termination date:** 2014-02-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-807-2013

## Citation

> AI Analytics. FDA recall D-807-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-807-2013. Source: US FDA. Licensed CC0.

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