Trazodone Hydrochloride tablets recalled for physical manufacturing defect
Zydus Pharmaceuticals is recalling Trazodone Hydrochloride 100mg tablets due to some tablets having a dent on the surface. No illnesses have been reported.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a Class III recall for a cosmetic physical defect (dented tablets) with no reported illnesses or injuries. Per the rubric, cosmetic defects are classified as Low severity.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling Trazodone Hydrochloride Tablets, USP, 100mg in bottles of 1,000 tablets (2,136,000 tablets total affected). The affected product was manufactured by Zydus Lifesciences Ltd. in India and distributed nationwide in the United States under Lot #EA00237A, expiring 04/30/2027.
The recall was initiated after the manufacturer received a product complaint that some tablets had a dent on the plain side of the tablet surface. This represents a failure to meet tablet specifications. No illnesses or injuries have been reported in association with this product.
Patients who have received this medication should check their tablets for the physical defect described. If dented tablets are found, patients should contact their pharmacy or healthcare provider. The affected lot can be identified by Lot #EA00237A and expiration date 04/30/2027.
The recalled product
- Product
- TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
- Brand
- TRAZODONE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug
- Hazard
- tablet-defect
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 # EA00237A
- Exp Date: 04/30/2027
UPCs (1)
- 0368382808011
Distribution
Distributed nationwide across the United States.
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