FDA Recall D-1111-2018

A-S Medication Solutions LLC. · Libertyville, IL

Class II Ongoing 2858 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0

Lot / code: Expiry, lot: 1/31/2019: 7293219; 6/30/2019: 7362231, 8074161, 8110184, 8197215, 8114178, 8115123; 9/30/2018: 7132187, 7160161, 7180150, 7268239

Quantity: 531 bottles

Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Recall record

Recall number: D-1111-2018
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide USA
Recall initiated: 2018-07-17
Classified by FDA Center: 2018-08-18
FDA published: 2018-08-29
Recalling firm: A-S Medication Solutions LLC.
Firm location: Libertyville, IL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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