Agency classClass IIOur severity:Severe FDA (Drugs)·D-1110-2018·Announced 2018-08-29

A-S Medication Solutions Recalls Valsartan and Hydrochlorothiazide Tablets

A-S Medication Solutions LLC is recalling Valsartan and Hydrochlorothiazide Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

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 involves the detection of a carcinogen impurity, which aligns with the rubric criterion for 'Severe' (FDA Class II with significant injury/property-damage reports or high-risk contaminants).

Plain-English summary

A-S Medication Solutions LLC is recalling Valsartan and Hydrochlorothiazide Tablets, 160 mg/12.5 mg, 90 tablets per bottle. The recall involves 524 bottles distributed nationwide in the United States. The specific lots affected are identified by the following expiration dates and lot numbers: 4/30/2019 (Lot 8033130) and 7/31/2019 (Lots 8068192, 8110183, 8080157, 8190195).

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of a carcinogen impurity in the active pharmaceutical ingredient (API) used to manufacture the drug product. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific NDC (54569-6480-0) and lot numbers listed above. If the product matches the recalled description, it should be discontinued and returned to the distributor or pharmacy for proper handling.

The recalled product

Product: Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0
Manufacturer: A-S Medication Solutions LLC.
Category: Drug — Prescription Medication
Hazard: carcinogen-impurity
cgmp-deviation
Affected units: 524

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 (6)

Expiry
lot: 4/30/2019: 8033130
7/31/2019: 8068192
8110183
8080157
8190195

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 →

Same manufacturer · A-S Medication Solutions LLC.

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Same hazard · carcinogen impurity