October 2019 FDA Recall Drug by Avantor Performance Materials Inc
D-0575-2020 - Failed Stability Specifications

This Class II drug recall was voluntarily initiated by Avantor Performance Materials Inc on October 30, 2019 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0575-2020

Reason for Recall
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Initiated
10-30-2019
Reported
12-04-2019
Quantity
a) 36 bottles; b) 85 bottles; c) 43 pails; d) 28 bottles and drums; e) 100 bottles and drums; f) 4 pails

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Avantor Performance Materials Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA, Canada, India, and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-16-2023
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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