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

FDA recall notice · announced June 26, 2013 · Hi-tech Pharmacal Co

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Subpotent; 24 month stability test station

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Batch 608917 (exp. 02/2014), and Batch 608204 (exp. 01/2014)
Quantity: lot 608917: 7764 bottles; lot 608204: 7476 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.