The Recall Desk
ModerateFDA (Drugs)·D-0232-2016·Announced 2015-11-25

Qualitest Recalls Hydrochlorothiazide Capsules Due to Particulate Matter

Vintage Pharmaceuticals is recalling 912 bottles of 12.5 mg Hydrochlorothiazide capsules because of the presence of particulate matter.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is particulate matter, which is a quality defect without reported serious injuries or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

Vintage Pharmaceuticals LLC, doing business as Qualitest Pharmaceuticals, is recalling 912 bottles of Hydrochlorothiazide Capsules, USP, 12.5 mg. The product is distributed in 3000-count bottles and is available by prescription only.

The recall is being conducted due to the presence of particulate matter in the capsules. The affected product is identified by NDC 0603-3855-93 and has expiration dates of 12/16. The specific lot codes involved are T084M14A, T085M14A, and T086M14A.

The product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.

The recalled product

Product
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93.
Affected units
912

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 (4)

  • T084M14A
  • T085M14A
  • T086M14A
  • Exp 12/16

Distribution

Distributed nationwide across the United States.