Drug product
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
D-603-2013
Product summary
- Event
- Event 65047
- Status
- Terminated
- Classification
- Class III
- Quantity
- lot 608917: 7764 bottles; lot 608204: 7476 bottles
- Official record key
drug-enforcement:D-603-2013
Official wording
Reason: Subpotent; 24 month stability test station
Code information: Batch 608917 (exp. 02/2014), and Batch 608204 (exp. 01/2014)
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent