Finasteride tablets recalled for manufacturing practice deviations
Accord Healthcare recalls 325,356 bottles of Finasteride 1 mg tablets due to manufacturing practice deviations identified during an FDA inspection. Affected batches were distributed in the United States, Puerto Rico, and Canada.
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: This is a Class II FDA recall with no reported illnesses or injuries. The recall addresses manufacturing practice deviations discovered during inspection rather than a specific identified contamination or product defect with documented harm. Per the rubric, recalls with no reported illnesses score at most 3; the manufacturing quality control nature supports a Moderate (2) rating.
Plain-English summary
Accord Healthcare, Inc. is recalling Finasteride (finasteride) 1 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA inspection.
The recall affects 325,356 bottles distributed across the United States, including Puerto Rico and Canada. Affected packages include 30-count and 90-count bottles with specific batch numbers and expiration dates: P2005979 (10/31/2023), P2100252 (12/31/2023), P2101710 (2/29/2024), P2100253 (12/31/2023), P2103035 (4/30/2024), and P2103036 (4/30/2024).
Consumers who have purchased affected Finasteride tablets should contact Accord Healthcare or their healthcare provider with questions about the recall.
The recalled product
- Product
- FINASTERIDE (FINASTERIDE)
- Brand
- FINASTERIDE
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug
- Hazard
- cgmp-deviation
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 (10)
- Batches: a) P2005979
- Exp. Date 10/31/2023
- P2100252
- Exp. Date 12/31/2023
- P2101710
- Exp. Date 2/29/2024
- b) P2100253
- P2103035
- Exp. Date 4/30/2024
- P2103036
UPCs (3)
- 0316729089104
- 316729089104
- 316729089159
Distribution
Distribution scope not specified by the agency.
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