Hi-Tech Pharmacal Co., Inc.
Hi-Tech Pharmacal Co., Inc. has 10 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest recall
- F-1380-2015 · Class II · Dec 23, 2014
- Latest 510(k)
- Dec 31, 2013
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 10 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 1 | Oct 4, 2026 | Not stated | Current |
| Inspections | 0 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| F-1380-2015 | Class II | FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO… | Dec 23, 2014 |
| F-0820-2017 | Class III | Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO… | Aug 25, 2014 |
| F-0817-2017 | Class III | Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO… | Jul 28, 2014 |
| D-0048-2015 | Class II | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC… | Apr 1, 2014 |
| D-389-2014 | Class III | Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal… | Oct 28, 2013 |
| D-66207-001 | Class III | GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz… | Sep 4, 2013 |
| D-888-2013 | Class III | Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech… | Jul 25, 2013 |
| D-603-2013 | Class III | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH… | Apr 30, 2013 |
| D-418-2013 | Class III | BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc… | Apr 8, 2013 |
| D-302-2013 | Class III | Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y… | Mar 11, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K132520 | NASAL EASE ALLERGY BLOCKER | Dec 31, 2013 |