Drug product
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
D-0068-2022
Product summary
- Event
- Event 88806
- Status
- Terminated
- Classification
- Class III
- Quantity
- 22,752 blister packs
- Official record key
drug-enforcement:D-0068-2022
Official wording
Reason: Failed Moisture Limits
Code information: Lot #: AC14635, Exp. Date 12/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Failed Moisture Limits