Class III · Low risk
Magnesium Chloride
Subpotent drug
Potassium Phosphate
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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.
Affected NDCs
10106-3248-01
10106-3248-02
10106-3248-03
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Potassium Phosphate Monobasic NDC 10106-3248 |
POTASSIUM PHOSPHATE, MONOBASIC 1 kg/kg | Crystal | Avantor Performance Materials, LLC | BULK INGREDIENT |
- Recalling firm
- Avantor Performance Materials Inc
- NDC code
- 10106-3248-1
- Origin
- KY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0575-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Avantor Performance Materials Inc
All 2019 recalls
Class III · Low risk
Magnesium Sulfate 7-Hydrate
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Other stability / shelf life recalls from 2019
All stability / shelf life recalls
Class II · Moderate risk
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Class III · Low risk
Smart Sense Regular Strength Aspirin Tablets
Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.
Class II · Moderate risk
Workvie Instant Pain Relieving Roll On
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Neogen-D
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
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