US Drug Recall Register
Class II · Moderate risk Terminated Initiated Oct 30, 2019 (7 years ago)

Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

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.

Recalling firm
Avantor Performance Materials Inc
NDC code
10106-3248-1
Origin
KY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0575-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Basic recalls

See all