D-1155-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 29, 2022
- Initiation Date
- June 3, 2022
- Termination Date
- August 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