Why it was recalled
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Product description
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00
Lot numbers, UPCs & expiration codes
Lot # B0438903-052118 70518-1220-00
Where it was sold
Product was distributed to a medical facility in South Carolina
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-0093-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 24, 2018
- FDA report date
- Oct 31, 2018
- Quantity
- 2 bottles of 90 tablets (180 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0093-2019, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 81395
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot # B0438903-052118 70518-1220-00
- Postal code
- 15701-3571
- Report date
- Oct 31, 2018
- Product type
- Drugs
- Recall number
- D-0093-2019
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 2 bottles of 90 tablets (180 tablets)
- Termination date
- Oct 29, 2018
- Reason for recall
- CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00
- Distribution pattern
- Product was distributed to a medical facility in South Carolina
- Recall initiation date
- Aug 24, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 24, 2018