Why it was recalled
Failed Moisture Limits
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: AC14635, Exp. Date 12/2022
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0068-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 12, 2021
- FDA report date
- Nov 3, 2021
- Quantity
- 22,752 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0068-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88806
- Address
- 2 Independence Way
- Code information
- Lot #: AC14635, Exp. Date 12/2022
- Postal code
- 08540-6620
- Report date
- Nov 3, 2021
- Product type
- Drugs
- Recall number
- D-0068-2022
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 22,752 blister packs
- Termination date
- Aug 31, 2023
- Reason for recall
- Failed Moisture Limits
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 12, 2021
- Initial firm notification
- Letter
- Center classification date
- Oct 26, 2021