# FDA recall D-0575-2020

> **Avantor Performance Materials Inc** · Class II · drug recall initiated 2019-10-30.

## Product

Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass bottles, product number 3248-01, NDC 10106-3248-1; b) 2.5KG glass bottles, product number 3248-05, NDC 10106-3248-2; c) 12KG pails, product number 3248-07, NDC 10106-3248-3; d) 1KT bottles and drums, product number 3248-X2; e) 1KT bottles and drums, product number 3248-X3; f) 12KG pails, product number 7390-19; Avantor Performance Materials, LLC, 100 Matsonford, Road, Suite 200, Radnor, PA 19087.

## Reason for recall

Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.

## Distribution

Nationwide in the USA, Canada, India, and Singapore

## Key facts

- **Recall number:** D-0575-2020
- **Recalling firm:** Avantor Performance Materials Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-10-30
- **Report date:** 2019-12-04
- **Termination date:** 2023-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Paris, KY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0575-2020

## Citation

> AI Analytics. FDA recall D-0575-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0575-2020. Source: US FDA. Licensed CC0.

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