FDA-Drug2018-09-19Class I
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.
Accord Healthcare, Inc.
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.
Sold states
Nationwide in the USA and Puerto Rico.
Affected count
46,632 bottles
Manufactured in
1009 Slater Rd Ste 210B, N/A, Durham, NC, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1206-2018Don't want to check this manually?
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