August 2018 FDA Recall Hydrochlorothiazide by Accord Healthcare, Inc.
D-1206-2018 - Product Mix-Up
This Class I drug recall was voluntarily initiated by Accord Healthcare, Inc. on August 21, 2018 for the product Hydrochlorothiazide. The FDA reported the reason for recall as product mix-up. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1206-2018
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
08-21-2018
09-19-2018
46,632 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and Puerto Rico.
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182-01.
Batch or Lot Expiration Information
Lot# Lot: PW05264, Exp. 11/2019
