FDAFDA · Food and drugs·Recall number D-1022-2018
Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.
Published August 8, 2018 · Recall initiated: July 26, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Carcinogen impurity detected in API used to manufacture drug product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- H J Harkins Company Inc dba Pharma Pac
- Distributor
- Product was distributed to a physician's office.
- Lot
- Lot # VSA000OV Manufacturer's original lot # 343B17015, exp date 02/19 NDC 43547-0369-09
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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