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, prod

FDA recall notice · announced December 4, 2019 · Avantor Performance Materials

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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.

Reason for recall

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

Notes

Distribution: Nationwide in the USA, Canada, India, and Singapore
Lot/code information: Batch: a) 0000226380; b) 0000224662, 0000224663, and 0000227641; c) 0000227640; d) 0000224809; e) 0000224818 and 0000225900; f) 0000224661; Retest Date 12/7/2023
Quantity: a) 36 bottles; b) 85 bottles; c) 43 pails; d) 28 bottles and drums; e) 100 bottles and drums; f) 4 pails
Status: Terminated
Products in this recall event:
- 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, produc (D-0575-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.