Antidepressant Medication Recalled for Excessive Active Ingredient Potency
Leading Pharma, LLC is recalling Clomipramine Hydrochloride Capsules (25mg) with Lot B14221 due to testing that found 110.6% of the labeled active ingredient strength. The medication was distributed nationwide.
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 FDA Class III recall involves superpotent capsules containing 110.6% of the labeled active ingredient strength. Although no illnesses or injuries have been reported, superpotency of a prescription medication presents a risk-of-harm condition where patients may receive unintended overdoses.
Plain-English summary
Leading Pharma, LLC is recalling Clomipramine Hydrochloride Capsules, USP 25mg, with Lot Number B14221 (expiration date 02/2023) that was distributed nationwide in the United States. Testing revealed the capsules contain 110.6% of the labeled active ingredient amount.
Clomipramine is a prescription antidepressant medication. Capsules containing greater amounts of active ingredient than labeled may result in patients receiving higher doses than prescribed, potentially causing adverse effects.
The recall involves 960 bottles of 100 capsules each, identified by NDC 69315-167-01 and Lot B14221. Patients who have this medication should contact their pharmacy or healthcare provider to confirm whether their supply is affected.
Patients should not discontinue clomipramine without medical guidance. Contact your pharmacist or doctor if you have this medication to determine whether your supply is from the affected lot and what action, if any, is appropriate.
The recalled product
- Product
- CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
- Brand
- CLOMIPRAMINE HYDROCHLORIDE
- Manufacturer
- Leading Pharma, LLC
- Category
- Drug — Antidepressant
- Hazard
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#: B14221
- Exp. Date 02/2023
UPCs (4)
- 0369315167014
- 0369315167038
- 0369315165034
- 0369315167090
Distribution
Distributed nationwide across the United States.
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