FDA recall D-0575-2020

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

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

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