Aurobindo Recalls Clozapine Tablets Due to Foreign Tablet Presence
Aurobindo Pharma USA is recalling 1,440 bottles of Clozapine 100mg tablets because a consumer reported finding 50mg tablets in the 100mg bottles.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: The recall is classified as FDA Class II, and the hazard involves a potential dosing error (50mg tablets in 100mg bottles) for a high-risk medication, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling 1,440 bottles of Clozapine Tablets USP 100mg, 500-count bottles. The recall was initiated following a consumer complaint that Clozapine Tablets 50mg were present in bottles labeled as 100mg.
The affected product is identified by Lot # CZSC20003-A and has an expiration date of 1/2022. The product was distributed nationwide in the U.S.A. The bottles are labeled as prescription-only (Rx only) and are manufactured in India.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be returned to the pharmacy or supplier for a refund or replacement. Patients should consult their healthcare provider regarding alternative medication options if they have been using the affected product.
The recalled product
- Product
- CLOZAPINE (CLOZAPINE)
- Brand
- CLOZAPINE
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 1,440
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 #: CZSC20003-A
- Exp 1/2022
UPCs (2)
- 0365862844019
- 0365862845016
Distribution
Distributed nationwide across the United States.
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