D-0068-2022 Class III Terminated
FDA drug recall D-0068-2022 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on October 12, 2021 and is designated Class III. Reason for recall: Failed Moisture Limits The recall status is terminated (terminated August 31, 2023). Affected quantity: 22,752 blister packs.
Recall Details
- Product Type
- Drugs
- Report Date
- November 3, 2021
- Initiation Date
- October 12, 2021
- Termination Date
- August 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,752 blister packs
Product Description
Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15
Reason for Recall
Failed Moisture Limits
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: AC14635, Exp. Date 12/2022