Why it was recalled
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Product description
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
Lot numbers, UPCs & expiration codes
Lot #: 051944A Exp. Date April - 2021; 1119124 Exp Date Oct - 2021; 062088 Exp Date June - 2022;
Where it was sold
Distributed Nationwide in the USA
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-0115-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 11, 2020
- FDA report date
- Dec 9, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- InvaTech Pharma Solutions, LLC
Original FDA data
Every field from FDA enforcement report D-0115-2021, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86708
- Address
- 40c Cotters Ln Ste A
- Code information
- Lot #: 051944A Exp. Date April - 2021; 1119124 Exp Date Oct - 2021; 062088 Exp Date June - 2022;
- Postal code
- 08816-2037
- Report date
- Dec 9, 2020
- Product type
- Drugs
- Recall number
- D-0115-2021
- Classification
- Class III
- Recalling firm
- InvaTech Pharma Solutions, LLC
- Termination date
- Jun 20, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Nov 11, 2020
- Initial firm notification
- Letter
- Center classification date
- Dec 3, 2020