Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product description
AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90
Lot numbers, UPCs & expiration codes
Lots: 17780 Exp. 09/2018; 18029 Exp. 09/2018; 18398 Exp. 09/2018; 18723 Exp. 09/2018; 19017 Exp. 02/2019; 19224 Exp. 02/2019; 20032 Exp. 08/2019; 20289 Exp. 08/2019; 21076 Exp. 08/2019; 21382 Exp. 08/2019
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-1176-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 18, 2018
- FDA report date
- Sep 12, 2018
- Quantity
- 12950 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Avkare Incorporated
Original FDA data
Every field from FDA enforcement report D-1176-2018, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 80940
- Address
- 114 S 1st St
- Code information
- Lots: 17780 Exp. 09/2018; 18029 Exp. 09/2018; 18398 Exp. 09/2018; 18723 Exp. 09/2018; 19017 Exp. 02/2019; 19224 Exp. 02/2019; 20032 Exp. 08/2019; 20289 Exp. 08/2019; 21076 Exp. 08/2019; 21382 Exp. 08/2019
- Postal code
- 38478-3216
- Report date
- Sep 12, 2018
- Product type
- Drugs
- Recall number
- D-1176-2018
- Classification
- Class II
- Recalling firm
- Avkare Incorporated
- Product quantity
- 12950 bottles
- Termination date
- May 7, 2020
- Reason for recall
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 18, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 6, 2018