Avantor magnesium chloride active pharmaceutical ingredient recalled as subpotent
Avantor Performance Materials is recalling one lot of bulk Magnesium Chloride 6-Hydrate active pharmaceutical ingredient because the material is subpotent. 36 bottles are affected.
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: FDA Class III recall for subpotency, which the rubric places in the 1-2 band; a potency shortfall rather than a purely cosmetic issue puts it at Moderate.
Plain-English summary
Avantor Performance Materials, LLC is recalling Magnesium Chloride, 6-Hydrate, Crystal, 500 g per bottle, a bulk active pharmaceutical ingredient, NDC 10106-2448-1. The action covers 36 bottles.
The stated reason is that the drug is subpotent, meaning it does not meet the declared strength. The FDA classified the action as Class III, its least serious classification, which is applied where use of the product is not likely to cause adverse health consequences.
The affected lot is 23G3161005, expiry 9/21/2027. Distribution was nationwide in the USA, and to Belgium and France. The material is supplied to manufacturers and compounders rather than sold to consumers.
Recipients should identify affected stock using the lot number above, quarantine it, and follow the instructions issued by Avantor.
The recalled product
- Product
- Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1
- Manufacturer
- Avantor Performance Materials LLC
- Affected units
- 36
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 (2)
- Lot 23G3161005
- Exp 9/21/2027
Distribution
Distributed nationwide across the United States.
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