Hydrochlorothiazide Tablet
FDA Recall NDC 29300-129
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Hydrochlorothiazide (NDC 29300-129). A significant event, classified as Class II, was initiated on Jul 30, 2015 by Unichem Pharmaceuticals (usa), Inc.. The reported reason for this action was: "Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Jul 30, 2015
Sep 02, 2015
4776 bottles
Recall Profile & Regulatory Data
Event ID
71860
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Unichem Pharmaceuticals Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 19, 2018
Product Description
Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10
Batch or Lot Expiration Information
Lot# : GHYL15028, Exp April 2018
Affected Packages Involved in this Recall
29300-128-01Product
29300-128-05Product
29300-128-10Product
29300-128-50Product
29300-129-01Product
29300-129-05Product
29300-129-10Product
29300-129-50Product
29300-485-01Product
29300-485-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
