Recall Enforment Report D-0069-2022

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 ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0069-202210-12-202111-03-2021Class III46,584 blister packsAllerClear 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 63981-724-15Failed Moisture LimitsOngoing
D-0068-202210-12-202111-03-2021Class III22,752 blister packsLoratadine-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 0904-5833-15Failed Moisture LimitsOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0904-5833Loratadine And Pseudoephedrine Sulfate Loratadine And Pseudoephedrine SulfateTablet, Film Coated, Extended ReleaseOralMajor PharmaceuticalsHuman Otc Drug
63981-724Kirkland Signature Allerclear D 24 Hr Extended ReleaseLoratadine And Pseudoephedrine SulfateTablet, Extended ReleaseOralKirkland-costco Wholesale CompanyHuman Otc Drug