Finasteride Tablets Recalled for Excessive Thickness in Specific Lot
Hetero Drugs Ltd. is recalling 20,412 bottles of Finasteride 5 mg tablets because one lot was found to be twice the standard thickness.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Hetero Drugs Ltd. is recalling 20,412 bottles of Finasteride Tablets, USP 5 mg. The affected product is Lot # FIN16002 with an expiration date of 03/2018. These prescription-only medications were manufactured for Camber Pharmaceuticals, Inc. and distributed only in New Jersey.
The recall was initiated because tablets in this specific lot were found to be twice the standard thickness. This is a Class III recall, indicating that the violation is not likely to cause adverse health consequences.
Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- FINASTERIDE (FINASTERIDE)
- Brand
- FINASTERIDE
- Manufacturer
- Hetero Drugs Ltd. - Unit 1
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 20,412
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 #: FIN16002
- Exp. 03/2018
UPCs (3)
- 0331722525305
- 0331722525909
- 0331722525107
Distribution
Distributed in 1 state:
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