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Hi-Tech Pharmacal Recalls
10 recalls on record · May 8, 2013 to December 28, 2016 · Drugs, Food & Beverage
Recalls by year
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14
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16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 28, 2016Food & BeverageFDA
Hi-Tech Pharmacal Co., Inc. recalls Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 117
Hazard: The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.
December 28, 2016Food & BeverageFDA
Hi-Tech Pharmacal Co., Inc. recalls Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 117
Hazard: Out-of-specification results for pH.
March 11, 2015Food & BeverageFDA
Hi-Tech Pharmacal Co., Inc. recalls FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11
Hazard: Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
November 5, 2014DrugsFDA
Hi-Tech Pharmacal Co., Inc. recalls HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufact
Hazard: Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.
January 1, 2014DrugsFDA
Hi-Tech Pharmacal Co., Inc. recalls Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, N
Hazard: Failed Stability Specification; product viscosity and or pH are below specification.
October 30, 2013DrugsFDA
Hi-Tech Pharmacal Co., Inc. recalls GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), a
Hazard: Subpotent; phenylephrine HCl
August 21, 2013DrugsFDA
Hi-Tech Pharmacal Co., Inc. recalls Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amity
Hazard: 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
June 26, 2013DrugsFDA
Hi-Tech Pharmacal Co., Inc. recalls HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMIT
Hazard: Subpotent; 24 month stability test station
May 22, 2013DrugsFDA
Hi-Tech Pharmacal Co., Inc. recalls BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl
Hazard: Subpotent; Cetylpyridinum Chloride
May 8, 2013DrugsFDA
Hi-Tech Pharmacal Co., Inc. recalls Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-88
Hazard: Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.