Why it was recalled
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Product description
Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada
Lot numbers, UPCs & expiration codes
VASERETIC 10-25MG TAB 100CT Lot # 12J022P exp. 9/30/2014 VASERETIC 10-25MG TAB 100CT Lot # 13G047P exp. 07/31/2015
Where it was sold
Nationwide
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-0018-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 21, 2014
- FDA report date
- Oct 22, 2014
- Quantity
- 205,853 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals North America LLC
Original FDA data
Every field from FDA enforcement report D-0018-2015, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68572
- Address
- 400 Somerset Corporate Blvd
- Code information
- VASERETIC 10-25MG TAB 100CT Lot # 12J022P exp. 9/30/2014 VASERETIC 10-25MG TAB 100CT Lot # 13G047P exp. 07/31/2015
- Postal code
- 08807
- Report date
- Oct 22, 2014
- Product type
- Drugs
- Recall number
- D-0018-2015
- Classification
- Class III
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Product quantity
- 205,853 bottles
- Termination date
- Aug 4, 2015
- Reason for recall
- Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada
- Distribution pattern
- Nationwide
- Recall initiation date
- May 21, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 10, 2014