Mylan Recalls Prasugrel Tablets Due to Dissolution Specification Failure
Mylan Pharmaceuticals is recalling 4,272 bottles of Prasugrel 5 mg tablets because they failed to meet dissolution specifications.
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, and the hazard involves a quality specification failure (dissolution) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 4,272 bottles of Prasugrel Tablets 5 mg, 30-count bottles. The product is identified by NDC 0378-5185-93, Lot # 3089793, and an expiration date of September 2020.
The recall was initiated because the tablets failed to meet dissolution specifications, resulting in low out-of-specification dissolution results. This means the tablets may not dissolve in the body as intended, potentially affecting the delivery of the medication.
The affected product was distributed nationwide within the United States. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for a replacement or further instructions.
The recalled product
- Product
- PRASUGREL (PRASUGREL)
- Brand
- PRASUGREL
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 4,272
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 #: 3089793
- Exp. Date September 2020
UPCs (1)
- 0303785185932
Distribution
Distributed nationwide across the United States.
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