RecallDepth
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, Radnor, PA 19087.

This recall has been terminated (originally issued December 4, 2019).

Company
Avantor Performance Materials Inc
Recall Initiated
October 30, 2019
Posted
December 4, 2019
Recall Number
D-0575-2020
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
a) 36 bottles; b) 85 bottles; c) 43 pails; d) 28 bottles and drums; e) 100 bottles and drums; f) 4 pails
Firm Location
Paris, KY, United States
Official Source
View on FDA website ↗

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

Lot / Code Info

Batch: a) 0000226380; b) 0000224662, 0000224663, and 0000227641; c) 0000227640; d) 0000224809; e) 0000224818 and 0000225900; f) 0000224661; Retest Date 12/7/2023

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