Recalls / Class III
Class IIID-0069-2022
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
- Brand name
- Kirkland Signature Allerclear D 24 Hr
- Generic name
- Loratadine And Pseudoephedrine Sulfate
- Active ingredients
- Loratadine, Pseudoephedrine Sulfate
- Route
- Oral
- NDC
- 63981-724
- FDA application
- ANDA076557
- Affected lot / code info
- AC09723, Exo, Date 11/2022
Why it was recalled
Failed Moisture Limits
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Kirkland-COSTCO WHOLESALE COMPANY
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 46,584 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-0069-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.