D-1155-2022 Class II Terminated
FDA drug recall D-1155-2022 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Jun 3, 2022 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specification; oversized tablet found in a bottle The recall status is terminated (terminated Aug 18, 2023). Affected quantity: 4608 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 29, 2022
- Initiation Date
- Jun 3, 2022
- Termination Date
- Aug 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4608 bottles
Product Description
Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.
Reason for Recall
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Distribution Pattern
nationwide within the United States
Code Information
Lot #: MHC1430A, Exp. Date 09/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1155-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026