Drug 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.
D-1206-2018
Product summary
- Event
- Event 80850
- Status
- Terminated
- Classification
- Class I
- Quantity
- 46,632 bottles
- Official record key
drug-enforcement:D-1206-2018
Official wording
Reason: Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Code information: Lot: PW05264, Exp. 11/2019
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Unknown
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.