Hi-Tech Pharmacal Co., Inc.

FDA Regulatory Profile

Summary

Total Recalls
10
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
F-1380-2015Class IIFERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INDecember 23, 2014
F-0820-2017Class IIIRx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INCAugust 25, 2014
F-0817-2017Class IIIRx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INCJuly 28, 2014
D-0048-2015Class IIHydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-1April 1, 2014
D-389-2014Class IIIAcyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal CoOctober 28, 2013
D-66207-001Class IIIGILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (September 4, 2013
D-888-2013Class IIIClobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech PharmacJuly 25, 2013
D-603-2013Class IIIHydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARApril 30, 2013
D-418-2013Class IIIBUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc CApril 8, 2013
D-302-2013Class IIIAcetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y.March 11, 2013