Food, drugs, devices › Hi-Tech Pharmacal Co., Inc.
Drug recall: HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMIT
FDA enforcement event 65047 is a drug recall by Hi-Tech Pharmacal Co., Inc. of Amityville, NY, initiated 30 Apr 2013 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 26% of the 370 drug enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 13 May 2016. Initiation: voluntary: firm initiated. Hi-Tech Pharmacal Co., Inc. has 10 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Hi-Tech Pharmacal Co., Inc., Amityville, NY.
Reason for recall
"Subpotent; 24 month stability test station"
Distribution
"Nationwide and Puerto Rico"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-603-2013 | 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 | lot 608917: 7764 bottles; lot 608204: 7476 bottles | Class III | Terminated | 26 Jun 2013 |
Context
Other enforcement events for Hi-Tech Pharmacal Co., Inc.
All 10 events for Hi-Tech Pharmacal Co., Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Subpotent; 24 month stability test station"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide and Puerto Rico"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 May 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.