FDA Recall D-1206-2018
Accord Healthcare, Inc. · Durham, NC
Class I — life-threatening Terminated 625 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-1206-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA and Puerto Rico.
- Recall initiated
- 2018-08-21
- Classified by FDA Center
- 2018-09-21
- FDA published
- 2018-09-19
- Terminated
- 2020-05-07
- Recalling firm
- Accord Healthcare, Inc.
- Firm location
- Durham, NC
Drug identification
- Brand name(s)
- HYDROCHLOROTHIAZIDE
- Generic name(s)
- HYDROCHLOROTHIAZIDE
- Manufacturer(s)
- Accord Healthcare Inc.
- NDC(s)
16729-182, 16729-183, 16729-184- Route(s)
- ORAL