Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product description
Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
Lot numbers, UPCs & expiration codes
Lot # B0335344-081717, exp. date 08/2018 Lot # B0363364-110917, exp. date 11/2018 Lot # B0391225-012218, exp. date 01/2019 Lot # B0408458-030618, exp. date 03/2019 Lot # B0384871-010318, exp. date 01/2019 Lot # B0436862-051518, exp. date 05/2019
Where it was sold
Product was distributed to three customers in FL and VA.
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-1101-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 10, 2018
- FDA report date
- Aug 22, 2018
- Quantity
- 21 bottles of 90 = 1890 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-1101-2018, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 80827
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot # B0335344-081717, exp. date 08/2018 Lot # B0363364-110917, exp. date 11/2018 Lot # B0391225-012218, exp. date 01/2019 Lot # B0408458-030618, exp. date 03/2019 Lot # B0384871-010318, exp. date 01/2019 Lot # B0436862-051518, exp. date 05/2019
- Postal code
- 15701-3571
- Report date
- Aug 22, 2018
- Product type
- Drugs
- Recall number
- D-1101-2018
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 21 bottles of 90 = 1890 tablets
- Termination date
- Oct 12, 2018
- Reason for recall
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
- Distribution pattern
- Product was distributed to three customers in FL and VA.
- Recall initiation date
- Aug 10, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2018