Avantor Recalls Magnesium Sulfate 7-Hydrate Due to Impurity Failures
Avantor Performance Materials is recalling 265 drums of Magnesium Sulfate 7-Hydrate for parenteral use because the product failed impurity specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Avantor Performance Materials, Inc. is recalling 265 drums of Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB. The recall was initiated because the product failed impurities/degradation specifications, resulting in out-of-specifications results for impurities.
The affected product is distributed in the US, including California, Illinois, and North Carolina, as well as in Canada. The recall covers two specific lots: Lot #0000115590 and Lot #0000117563, both with an expiration date of 5/10/17.
This is an FDA Class III recall, which indicates that the use of or exposure to the product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.
- Manufacturer
- Avantor Performance Materials Inc
- Category
- Drug — Pharmaceutical Ingredient
- Hazard
- Affected units
- 265
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 (4)
- Lot #: 0000115590
- Expiry: 5/10/17
- Lot #: 0000117563
- Expiry: 5/10/17.
Distribution
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