Status
Terminated
Drug Enforcement D-603-2013
Subpotent; 24 month stability test station
Classification
Class III
Report Date
June 26, 2013
Termination Date
May 13, 2016
Product Information
- Product description
- 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
- Product quantity
- lot 608917: 7764 bottles; lot 608204: 7476 bottles
- Reason for recall
- Subpotent; 24 month stability test station
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
- Address
-
369 Bayview Ave
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-603-2013
- Event ID
- 65047
- Recall initiation date
- April 30, 2013
- Center classification date
- June 14, 2013
- Code info
- Batch 608917 (exp. 02/2014), and Batch 608204 (exp. 01/2014)
- More code info
- —