Amerisource Recalls Hydrochlorothiazide Capsules Due to Particulate Matter
Amerisource Health Services is recalling specific lots of Hydrochlorothiazide capsules because they contain particulate matter.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (particulate matter) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Amerisource Health Services is recalling 2,784 cartons of Hydrochlorothiazide Capsules, USP, 12.5 mg. The affected product is packaged in 100-count cartons with 10 capsules per blister pack. The recall covers Lot # 151379 and Lot #151380, which have an expiration date of 12/16.
The recall was initiated due to the presence of particulate matter in the capsules. The product was distributed nationwide. The agency has classified this recall as Class II.
Consumers who have this product should stop using it and contact their pharmacist or healthcare provider for guidance on disposal or replacement.
The recalled product
- Product
- HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Prescription Medication
- Hazard
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 (2)
- Lot # 151379 and Lot #151380
- Exp 12/16
Distribution
Distributed nationwide across the United States.
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