Recalls / Class III
Class IIID-0068-2022
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
- Brand name
- Loratadine And Pseudoephedrine Sulfate
- Generic name
- Loratadine And Pseudoephedrine Sulfate
- Active ingredients
- Loratadine, Pseudoephedrine Sulfate
- Route
- Oral
- NDC
- 0904-5833
- FDA application
- ANDA076557
- Affected lot / code info
- Lot #: AC14635, Exp. Date 12/2022
Why it was recalled
Failed Moisture Limits
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 22,752 blister packs
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-10-12
- FDA classified
- 2021-10-26
- Posted by FDA
- 2021-11-03
- Terminated
- 2023-08-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0068-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.