Why it was recalled
Failed Moisture Limits
Product description
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
Lot numbers, UPCs & expiration codes
AC09723, Exo, Date 11/2022
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-0069-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 12, 2021
- FDA report date
- Nov 3, 2021
- Quantity
- 46,584 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0069-2022, 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
- AC09723, Exo, Date 11/2022
- Postal code
- 08540-6620
- Report date
- Nov 3, 2021
- Product type
- Drugs
- Recall number
- D-0069-2022
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 46,584 blister packs
- Termination date
- Aug 31, 2023
- Reason for recall
- Failed Moisture Limits
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 12, 2021
- Initial firm notification
- Letter
- Center classification date
- Oct 26, 2021