The Recall Desk
HighFDA (Drugs)·D-0565-2016·Announced 2016-01-20

Amerisource Recalls Hydrochlorothiazide Capsules Due to Particulate Matter

Amerisource Health Services is recalling specific lots of Hydrochlorothiazide capsules because they contain particulate matter.

What this means for you

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

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.