Class III
Terminated
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
- Company
- Hi-Tech Pharmacal Co., Inc.
- Recall Initiated
- April 30, 2013
- Posted
- June 26, 2013
- Recall Number
- D-603-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- lot 608917: 7764 bottles; lot 608204: 7476 bottles
- Firm Location
- Amityville, NY, United States
Reason for Recall
Subpotent; 24 month stability test station
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Batch 608917 (exp. 02/2014), and Batch 608204 (exp. 01/2014)
More recalls by Hi-Tech Pharmacal Co., Inc.
Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC...
Dec 28, 2016 · Class III
Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC...
Dec 28, 2016 · Class III
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, IN...
Mar 11, 2015 · Class II
Other recent Class III Drug recalls
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Via...
Slate Run Pharmaceuticals
· Mar 4, 2026
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceutica...
Unichem Pharmaceuticals Usa Inc.
· Feb 18, 2026
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL),...
Haleon Us Holdings Llc
· Feb 4, 2026
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceutic...
Novadoz Pharmaceuticals Llc
· Feb 4, 2026
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd.,...
Cipla Usa, Inc.
· Jan 28, 2026