Drug recall D-1206-2018

Class I Terminated reported Sep 19, 2018

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.

Reason for recall

Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.

Lots and codes

Lot: PW05264, Exp. 11/2019

Recall details

Recalling firm
Accord Healthcare, Inc., Durham, NC
Quantity
46,632 bottles
Distribution
Nationwide in the USA and Puerto Rico.
Type
Voluntary: Firm initiated
Recall initiated
August 21, 2018
Terminated
May 7, 2020

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