Injectable drug recall: Milrinone Lactate fails impurity and degradation specifications
Milrinone Lactate Injection is recalled due to failed impurity and degradation specifications. The affected lot should not be used.
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 2/5 (Moderate).
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 with no reported illnesses or injuries. The product failed quality specifications (impurities and degradation), indicating a potential safety concern, but no adverse events have been documented.
Plain-English summary
Caplin Steriles Limited, the manufacturer, and Armas Pharmaceuticals Inc., the distributor, are recalling Milrinone Lactate Injection, USP 20mg/20mL (Lot #90000228) because the product failed impurity and degradation specifications. This is an intravenous injection used in medical settings, and approximately 19,820 vials were distributed.
The recalled lot was distributed nationwide. Healthcare providers and patients who may have received this product should not use it and should contact their healthcare provider or pharmacist. For instructions on return, replacement, or disposal of the affected product, contact Armas Pharmaceuticals Inc.
The recalled product
- Product
- MILRINONE LACTATE (MILRINONE LACTATE)
- Brand
- MILRINONE LACTATE
- Manufacturer
- Caplin Steriles Limited
- Category
- Drug — Injectable
- Hazard
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 (1)
- Lot #: 90000228
UPCs (4)
- 0372485503018
- 0372485501014
- 0372485502011
- 0372485502103
Distribution
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