Lupin Recalls Paroxetine Extended-Release Tablets Due to Dissolution Failure
Lupin Pharmaceuticals is recalling Paroxetine Extended-Release Tablets because they failed dissolution testing during stability studies.
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 FDA classified this recall as 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
Lupin Pharmaceuticals Inc. is recalling Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottles. The recall involves 12,480 bottles distributed nationwide in the USA. The specific lots affected are H605712, H605711, and H605710 with an expiration date of November 2018, and lots H702255 and H702202 with an expiration date of March 2019.
The recall was initiated because the product failed to meet dissolution specifications. Out-of-specification results were observed in dissolution testing during a 3-month long-term stability study. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they are currently using the affected medication.
The recalled product
- Product
- PAROXETINE (PAROXETINE)
- Brand
- PAROXETINE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 12,480
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 (6)
- Lots: H605712
- H605711
- H605710
- EXP November 2018
- H702255
- H702202 EXP March 2019
Distribution
Distributed nationwide across the United States.
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