Home / Recalls / A-S Medication Solutions LLC. / D-1109-2018

D-1109-2018 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
178 bottles

Product Description

Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China

Reason for Recall

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

Distribution Pattern

Nationwide USA

Code Information

Expiry, lot: [30-count] 11/30/2018: 7258177, 7276228; 2/28/2019: 7212260; [90-count] 11/30/2018: 7208140; 2/28/2019: 7212261, 7221155, 7222161; 8/31/2019: 8109171; 9/30/2019: 8109170

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-1108-2018 Class II — Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle ( (July 17, 2018)
  • D-1110-2018 Class II — Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiaz (July 17, 2018)
  • D-1111-2018 Class II — Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiaz (July 17, 2018)
  • D-0839-2016 Class III — Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle (April 22, 2016)