D-0069-2022 Class III Terminated
FDA drug recall D-0069-2022 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: 46,584 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
- 46,584 blister packs
Product Description
AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15
Reason for Recall
Failed Moisture Limits
Distribution Pattern
Nationwide within the United States
Code Information
AC09723, Exo, Date 11/2022