Avantor Recalls Potassium Phosphate Bulk Chemical for Excess Iron Content
Avantor Performance Materials Inc is recalling bulk Potassium Phosphate, Monobasic, Crystal due to failed stability specifications for iron content.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The specific defect is a failure in stability specifications for iron content, which is a quality control issue rather than a direct acute hazard like a pathogen or structural defect.
Plain-English summary
Avantor Performance Materials Inc is voluntarily recalling specific lots of Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical. The recall affects products packaged in 500g glass bottles, 2.5kg glass bottles, 12kg pails, and 1kt bottles and drums. The affected products are identified by specific product numbers and NDC codes, including NDC 10106-3248-1, NDC 10106-3248-2, and NDC 10106-3248-3.
The recall was initiated because the product failed stability specifications, specifically exceeding compendia and the firm's specifications for iron content. The affected batches have a retest date of 12/7/2023. The total quantity recalled includes 36 bottles, 85 bottles, 43 pails, 28 bottles and drums, 100 bottles and drums, and 4 pails.
The product was distributed nationwide in the USA, Canada, India, and Singapore. Consumers and healthcare facilities should check their inventory for the specific batch numbers and product numbers listed in the recall notice. If the product is found, it should be quarantined and returned to the supplier or disposed of according to local regulations. No adverse health consequences have been reported in the source text.
The recalled product
- 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 1
- Manufacturer
- Avantor Performance Materials Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Batch: a) 0000226380
- b) 0000224662
- 0000224663
- and 0000227641
- c) 0000227640
- d) 0000224809
- e) 0000224818 and 0000225900
- f) 0000224661
- Retest Date 12/7/2023
Distribution
Distributed nationwide across the United States.
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