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.
Reported: September 19, 2018 Initiated: August 21, 2018 #D-1206-2018
Product Description
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.
Details
- Recalling Firm
- Accord Healthcare, Inc.
- Units Affected
- 46,632 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Accord Healthcare, Inc.. Units affected: 46,632 bottles.
Why was this product recalled? ▼
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 19, 2018. Severity: Critical. Recall number: D-1206-2018.
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