Avantor Performance Materials Inc recalls Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass…

Recall date

October 30, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0575-2020

FDA classification

Class II

Brand / firm

Avantor Performance Materials Inc

Sold / distributed

Nationwide in the USA, Canada, India, and Singapore

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.