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.
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' (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
- 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.
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