A-S Medication Solutions Recalls Valsartan and Hydrochlorothiazide Tablets
A-S Medication Solutions LLC is recalling 531 bottles of Valsartan and Hydrochlorothiazide Tablets due to the detection of a carcinogen impurity in the active pharmaceutical ingredient.
What this means for you
Illness, injury, or structural failure has been reported. 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 involves the detection of a carcinogen impurity, which aligns with the rubric criterion for 'Severe' severity (FDA Class II with significant health risk).
Plain-English summary
A-S Medication Solutions LLC is voluntarily recalling 531 bottles of Valsartan and Hydrochlorothiazide Tablets, 320 mg/25 mg, 90-count bottles. The product was manufactured by Arrow Pharm (Malta) LTD and distributed nationwide in the United States. The recall is being conducted because a carcinogen impurity was detected in the active pharmaceutical ingredient (API) used to manufacture the drug product.
The affected product is identified by NDC 54569-6488-0. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring in 2018, 2019, and 2020. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatment options. Consumers should check their medication bottles for the NDC number and lot numbers listed in the official recall notice to determine if they are affected.
The recalled product
- 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
- Manufacturer
- A-S Medication Solutions LLC.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 531
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 (12)
- Expiry
- lot: 1/31/2019: 7293219
- 6/30/2019: 7362231
- 8074161
- 8110184
- 8197215
- 8114178
- 8115123
- 9/30/2018: 7132187
- 7160161
- 7180150
- 7268239
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by A-S Medication Solutions LLC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · A-S Medication Solutions LLC.
See all →- HighMetformin Hydrochloride Extended-Release Tablets Recalled for Foreign Tablet Contamination
FDA (Drugs) · 2025-04-02
- SevereAcetaminophen tablets incorrectly labeled with aspirin drug facts information
FDA (Drugs) · 2024-08-14
- LowCetirizine Hydrochloride 10 mg Tablets Labeling Error Recall
FDA (Drugs) · 2021-11-17
- ModerateFDA Recalls Acetaminophen in Health Kits Due to Labeling Error
FDA (Drugs) · 2021-05-12
- SevereA-S Medication Solutions Recalls Valsartan Tablets Due to Carcinogen Impurity
FDA (Drugs) · 2018-08-29
Same hazard · carcinogen impurity
See all →- SevereMacleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Carcinogen
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Irbesartan Bulk Ingredient Due to Carcinogen Impurity
FDA (Drugs) · 2018-11-07
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12