Hi-Tech Pharmacal recalls
FDA enforcement reports naming Hi-Tech Pharmacal Co., Inc. as the recalling firm.
- Recall reports
- 9
- Class I (serious)
- 0
- Most recent report
- Dec 28, 2016
- Dec 28, 2016Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL)Food · Hi-Tech Pharmacal Co., Inc.Out-of-specification results for pH.Class III
- Dec 28, 2016Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL)Food · Hi-Tech Pharmacal Co., Inc.The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.Class III
- Mar 11, 2015FERROUS SULFATE ELIXIR 220 mg/5 mLFood · Hi-Tech Pharmacal Co., Inc.Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.Class II
- Nov 5, 2014HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mLDrug · Hi-Tech Pharmacal Co., Inc.Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.Class II
- Jan 1, 2014Acyclovir Oral Suspension, USP 200 mg/5 mLDrug · Hi-Tech Pharmacal Co., Inc.Failed Stability Specification; product viscosity and or pH are below specification.Class III
- Aug 21, 2013Clobetasol Propionate Cream, USP, 0Drug · Hi-Tech Pharmacal Co., Inc.Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USPClass III
- Jun 26, 2013HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 flDrug · Hi-Tech Pharmacal Co., Inc.Subpotent; 24 month stability test stationClass III
- May 22, 2013BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol…Drug · Hi-Tech Pharmacal Co., Inc.Subpotent; Cetylpyridinum ChlorideClass III
- May 8, 2013Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal CoDrug · Hi-Tech Pharmacal Co., Inc.Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.Class III