FDAAugust 21, 2018drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

accord healthcareaccord

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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