FDAJuly 26, 2018drug
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Carcinogen impurity detected in API used to manufacture drug product.
What to do
FDA enforcement status: Terminated
Brands named
h j harkins company inc dba pharma pac
UPCs
43547036909
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCRaychy Children's Light Sneakers Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Coin Batteries; Imported by Carina and Rambo2026-06-25
- CPSCVeseacky Pajama Sets Recalled Due to Risk of Serious Injury Death from Burn Hazard; Violate Mandatory Standards for Children's Sleepwear2026-06-18
- CPSCArizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by 7111495 Canada2026-06-18
- CPSCLiKee Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Standard for Toys; Sold on Amazon by ChilanTech2026-06-11
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