Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product description
Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
Lot numbers, UPCs & expiration codes
Lot # B0383153-122917; Exp. 12/18
Where it was sold
Product was distributed to 3 medical facilities in Florida.
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-1021-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 17, 2018
- FDA report date
- Aug 8, 2018
- Quantity
- 3 HDPE 90-count bottles (270 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-1021-2018, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 80646
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot # B0383153-122917; Exp. 12/18
- Postal code
- 15701-3571
- Report date
- Aug 8, 2018
- Product type
- Drugs
- Recall number
- D-1021-2018
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 3 HDPE 90-count bottles (270 tablets)
- Termination date
- Oct 17, 2018
- Reason for recall
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
- Distribution pattern
- Product was distributed to 3 medical facilities in Florida.
- Recall initiation date
- Jul 17, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2018