Multi event Drug Recall Enforcement Report Class III voluntary initiated by SUN PHARMACEUTICAL INDUSTRIES INC, originally initiated on 10-12-2021 for the product 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 The product was recalled due to failed moisture limits. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0069-2022 | 10-12-2021 | 11-03-2021 | Class III | 46,584 blister packs | 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 | Failed Moisture Limits | Terminated |
| D-0068-2022 | 10-12-2021 | 11-03-2021 | Class III | 22,752 blister packs | 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 | Failed Moisture Limits | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0904-5833 | Loratadine And Pseudoephedrine Sulfate | Loratadine And Pseudoephedrine Sulfate | Tablet, Film Coated, Extended Release | Oral | Major Pharmaceuticals | Human Otc Drug |
| 63981-724 | Kirkland Signature Allerclear D 24 Hr Extended Release | Loratadine And Pseudoephedrine Sulfate | Tablet, Extended Release | Oral | Kirkland-costco Wholesale Company | Human Otc Drug |
