Methylergonovine Maleate tablets recalled for failed dissolution specifications
Amneal Pharmaceuticals recalls Methylergonovine Maleate 0.2mg tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially reducing medication effectiveness.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall affecting a prescription medication used for postpartum hemorrhage treatment. While no illnesses or injuries have been reported, the manufacturing defect (failed dissolution specifications) represents a risk of harm where drug efficacy may be compromised.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC has issued a nationwide recall of Methylergonovine Maleate 0.2mg tablets. The recall affects 2,784 bottles (Lot #BJ01922A, expiration date 03/2024) distributed nationwide. The tablets are being recalled because they failed to meet dissolution specifications during quality control testing.
Methylergonovine is a prescription medication used to treat and prevent postpartum hemorrhage. If the tablets do not dissolve properly, the medication may not be absorbed as intended, potentially reducing its effectiveness.
Patients currently taking this medication should contact their healthcare provider or pharmacist to determine whether they may have been affected and to discuss next steps. Do not stop taking the medication without consulting a healthcare provider.
The recalled product
- Product
- METHYLERGONOVINE MALEATE (METHYLERGONOVINE)
- Brand
- METHYLERGONOVINE MALEATE
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Category
- Drug
- Hazard
- dissolution-failure
- reduced-efficacy
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 #: BJ01922A
- exp. date 03/2024
Distribution
Distributed nationwide across the United States.
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