CLASS II Drug recall · Reported 4 Dec 2019 · FDA Enforcement Report
Potassium Phosphate, Monobasic, Crystal, NF recalled
Avantor Performance Materials is recalling Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical, distributed nationwide in the US. The recall was initiated on 30 Oct 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0575-2020
- FDA event ID
- 84188
- Recalling firm
- Avantor Performance Materials, Paris, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Oct 2019
- FDA classified
- 6 Dec 2019
- Reported
- 4 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
Timeline
| 30 Oct 2019 | Recall initiated by company | |
| 4 Dec 2019 | Published in enforcement report | +35 days |
| 6 Dec 2019 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA, Canada, India, and Singapore
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Which lots are affected?
Batch: a) 0000226380; b) 0000224662, 0000224663, and 0000227641; c) 0000227640; d) 0000224809; e) 0000224818 and 0000225900; f) 0000224661; Retest Date 12/7/2023
Where was it sold?
Nationwide in the USA, Canada, India, and Singapore
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Avantor Performance Materials
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Magnesium Chloride, 6-Hydrate, Crystal recalled | Avantor Performance Materials | Potency & Assay | Nationwide |
| Drug | CLASS III | Magnesium Sulfate 7-Hydrate recalled by Avantor Performance Materials | Avantor Performance Materials | Potency & Assay | CA, IL, NC |
Other Potassium recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Potassium Acetate Injection, 2 mEq/mL recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS III | Potassium Acetate Injection, USP 40 mEq recalled | Exela Pharma Sciences | Packaging Defects | Nationwide |
| Drug | CLASS II | Potassium Citrate Extended-Release Tablets, USP, 15 mEq recalledPotassium Citrate | Vensun Pharmaceuticals | Other | PR |
| Drug | CLASS II | Potassium Citrate Extended-Release Tablets, USP, 10 mEq recalledPotassium Citrate | Vensun Pharmaceuticals | Other | PR |
| Drug | CLASS II | Potassium PHOSphate in 0.9% Sodium Chloride Injection recalled | PharMedium Services | Sterility | Nationwide |