Hi-Tech Pharmacal Co.

10 recalls •

🍎 Food 💊 Drugs

• Categories: Dietary Supplements, Other Foods, Prescription Drugs, Other Drugs

Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701

🍎 Food Class I - Dangerous

Out-of-specification results for pH.

Jul 28, 2014 Dietary Supplements View Details →

Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701

🍎 Food Class I - Dangerous

The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.

Aug 25, 2014 Dietary Supplements View Details →

FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701

🍎 Food Class I - Dangerous

Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.

Dec 23, 2014 Other Foods View Details →

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702-052-16, Rx Only, Manufactured for: KVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.

💊 Drugs Class I - Dangerous

Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.

Apr 1, 2014 Prescription Drugs Nationwide View Details →

Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.

💊 Drugs Class I - Dangerous

Failed Stability Specification; product viscosity and or pH are below specification.

Oct 28, 2013 Prescription Drugs Nationwide View Details →

GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716

💊 Drugs Class I - Dangerous

Subpotent; phenylephrine HCl

Sep 4, 2013 Other Drugs View Details →

Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.

💊 Drugs Class I - Dangerous

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 USP

Jul 25, 2013 Prescription Drugs Nationwide View Details →

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

💊 Drugs Class I - Dangerous

Subpotent; 24 month stability test station

Apr 30, 2013 Prescription Drugs Nationwide View Details →

BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manufactured for GIL PHARMACEUTICAL CORP, PONCE, PUERTO RICO 00717-1565 -- NDC 58552-103-01

💊 Drugs Class I - Dangerous

Subpotent; Cetylpyridinum Chloride

Apr 8, 2013 Prescription Drugs View Details →

Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.

💊 Drugs Class I - Dangerous

Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.

Mar 11, 2013 Prescription Drugs Nationwide View Details →