FDA Drug recall D-0575-2020
Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass bottles, product num…
- FDA Drug
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass bottles, product num… by Avantor Performance Materials, citing failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0575-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-30 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avantor Performance Materials |
| Distribution | US |
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
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Identifiers
| code_info | Batch: a) 0000226380; b) 0000224662, 0000224663, and 0000227641; c) 0000227640; d) 0000224809; e) 0000224818 and 000022…Batch: a) 0000226380; b) 0000224662, 0000224663, and 0000227641; c) 0000227640; d) 0000224809; e) 0000224818 and 0000225900; f) 0000224661; Retest Date 12/7/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0575-2020%22
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