Potassium Phosphate — Class II drug recall D-0575-2020
Terminated recall by Avantor Performance Materials Inc, reported 2019-12-04, distributed nationwide. Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
| Recall number | D-0575-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avantor Performance Materials Inc, Paris, KY, United States |
| Recall initiated | 2019-10-30 |
| Classified | 2019-12-06 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2023-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, IN, SG |
| Reason classes | specification failure |
| NDC | 10106-3248-01, 10106-3248-02, 10106-3248-03 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0575-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.