PlainRecalls
FDA Drug Moderate Class II Terminated

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,

Reported: December 4, 2019 Initiated: October 30, 2019 #D-0575-2020

Product Description

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.

Details

Units Affected
a) 36 bottles; b) 85 bottles; c) 43 pails; d) 28 bottles and drums; e) 100 bottles and drums; f) 4 pails
Distribution
Nationwide in the USA, Canada, India, and Singapore
Location
Paris, KY

Frequently Asked Questions

What product 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.. Recalled by Avantor Performance Materials Inc. Units affected: a) 36 bottles; b) 85 bottles; c) 43 pails; d) 28 bottles and drums; e) 100 bottles and drums; f) 4 pails.
Why was this product recalled? ▼
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 4, 2019. Severity: Moderate. Recall number: D-0575-2020.

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