Finasteride Tablets Recalled Nationwide for Manufacturing Practice Deviations
Direct Rx is recalling 19 bottles of Finasteride 5 mg Tablets nationwide due to cGMP deviations. The firm initiated this recall voluntarily.
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 FDA classified this as a Class II recall initiated voluntarily for manufacturing practice deviations. Per the severity rubric, voluntary precautionary recalls without identified specific hazards warrant a Moderate severity rating.
Plain-English summary
Direct Rx is recalling 19 bottles of Finasteride, USP, 5 mg Tablets distributed nationwide. The recalled bottles are 90-count packages (NDC 61919-0733-90) from lot numbers 19AU2205 and 12OC2211, both expiring 12/31/24.
The recall was initiated voluntarily by Direct Rx on March 13, 2023, due to cGMP deviations discovered during manufacturing. The FDA classified this as a Class II recall. The recall was terminated on June 17, 2024.
The recalled product
- Product
- Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
- Manufacturer
- Direct Rx
- Category
- Drug — Finasteride
- Hazard
- Affected units
- 19
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
- expiry: 19AU2205
- exp 12/31/24
- 12OC2211
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Direct Rx under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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