Home / Recalls / A-S Medication Solutions LLC. / D-1111-2018

D-1111-2018 Class II Ongoing

Recalled by A-S Medication Solutions LLC. — Libertyville, IL

Recall Details

Product Type
Drugs
Report Date
August 29, 2018
Initiation Date
July 17, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
531 bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide USA

Code Information

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

Other recalls by A-S Medication Solutions LLC.

  • D-0292-2025 Class II — METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S M (February 25, 2025)
  • D-0631-2024 Class I — Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged B (June 21, 2024)
  • D-0096-2022 Class III — Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Me (October 5, 2021)
  • D-0358-2021 Class I — Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, (March 2, 2021)
  • D-1109-2018 Class II — Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (ND (July 17, 2018)
  • D-1110-2018 Class II — Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiaz (July 17, 2018)
  • D-1108-2018 Class II — Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle ( (July 17, 2018)
  • D-0839-2016 Class III — Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle (April 22, 2016)