The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1022-2018·Announced 2018-08-08

Valsartan tablets recalled due to carcinogen impurity in active ingredient

H.J. Harkins Co. is recalling Valsartan tablets 160 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the product.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a carcinogen impurity, which aligns with the rubric criterion for Severe severity (FDA Class II with significant health risks).

Plain-English summary

H.J. Harkins Company Inc dba Pharma Pac is recalling Valsartan tablets 160 mg, 90-count bottles (NDC 43547-0369-09). The tablets are yellow, capsule-shaped, biconvex, film-coated, and debossed with '343' on one side and 'HH' on the other. The specific lot affected is # VSA000OV, with a manufacturer's original lot # 343B17015 and an expiration date of 02/19.

The recall was initiated because a carcinogen impurity was detected in the active pharmaceutical ingredient (API) used to manufacture the drug product. The source text does not specify the name of the impurity or the quantity of units affected beyond the product description.

The product was distributed to a physician's office. Patients who have been prescribed this specific lot of Valsartan should contact their healthcare provider for guidance on alternative treatment options. Do not take the recalled product until further notice.

The recalled product

Product
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.
Manufacturer
H J Harkins Company Inc dba Pharma Pac
Category
Drug — Antihypertensive
Hazard
Affected units
540

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # VSA000OV Manufacturer's original lot # 343B17015
  • exp date 02/19 NDC 43547-0369-09

Distribution

Distribution scope not specified by the agency.

Related recalls

Same manufacturer · H J Harkins Company Inc dba Pharma Pac

See all →

Same hazard · carcinogen impurity

See all →

Similar recalls