FDA Recalls Prasugrel Tablets for Failed Dissolution Specifications
Golden State Medical Supply Inc. is recalling 2,601 bottles of Prasugrel 5 mg tablets due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting drug absorption.
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 of a critical blood thinner where dissolution failure could prevent proper drug absorption. No illnesses or injuries have been reported, classifying this as a risk-of-harm product without reported injury, meeting the rubric criterion for score 3 (High).
Plain-English summary
Golden State Medical Supply Inc. is recalling Prasugrel 5 mg tablets packaged in 30-tablet bottles. The recall affects approximately 2,601 bottles distributed nationwide.
The tablets failed to meet dissolution specifications, meaning they may not dissolve properly in the body. This could affect the proper absorption and effectiveness of the medication.
Prasugrel is a prescription blood thinner used to prevent blood clots in patients who have had a heart attack or stroke. Patients taking affected lots (GS059908, GS060228, GS060709, GS061233, GS061704, GS062158, GS062405 with expiration date 04/30/2026) should contact their healthcare provider.
Patients should not stop taking their medication without speaking to their healthcare provider first. They should check with their pharmacy to determine if they have received any affected bottles and consult their physician about next steps.
The recalled product
- Product
- PRASUGREL (PRASUGREL)
- Brand
- PRASUGREL
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Antiplatelet
- Hazard
- dissolution-failure
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 (8)
- Lot no's: GS059908
- GS060228
- GS060709
- GS061233
- GS061704
- GS062158
- GS062405
- Exp.: 04/30/2026
Distribution
Distributed nationwide across the United States.
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