Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product description
Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9
Lot numbers, UPCs & expiration codes
Lot # G2017F NDC 68788-6882-9
Where it was sold
Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.
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-1107-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 15, 2018
- FDA report date
- Aug 29, 2018
- Quantity
- 9 bottles consisting of 90 tables each bottle
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc
Original FDA data
Every field from FDA enforcement report D-1107-2018, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 80840
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot # G2017F NDC 68788-6882-9
- Postal code
- 92807-1801
- Report date
- Aug 29, 2018
- Product type
- Drugs
- Recall number
- D-1107-2018
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc
- Product quantity
- 9 bottles consisting of 90 tables each bottle
- Termination date
- Jan 18, 2019
- Reason for recall
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9
- Distribution pattern
- Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.
- Recall initiation date
- Aug 15, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 17, 2018