D-1206-2018 Class I Terminated
FDA drug recall D-1206-2018 was initiated by Accord Healthcare, Inc. on Aug 21, 2018 and is designated Class I. 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. The recall status is terminated (terminated May 7, 2020). Affected quantity: 46,632 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 19, 2018
- Initiation Date
- Aug 21, 2018
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46,632 bottles
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lot: PW05264, Exp. 11/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1206-2018
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026