Drug 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.
D-0575-2020
Product summary
- Event
- Event 84188
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 36 bottles; b) 85 bottles; c) 43 pails; d) 28 bottles and drums; e) 100 bottles and drums; f) 4 pails
- Official record key
drug-enforcement:D-0575-2020
Official wording
Reason: Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
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
Distribution pattern: Nationwide in the USA, Canada, India, and Singapore
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications