Drug product
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
D-0247-2026
Product summary
- Event
- Event 98184
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 2,136 1000-count bottles
- Official record key
drug-enforcement:D-0247-2026
Official wording
Reason: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Code information: Lot # EA00237A, Exp Date: 04/30/2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.