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Hi-Tech Pharmacal Co., Inc.

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20135
20142
20162
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FDA Recall United States Terminated Historical recordClass III

Hi-Tech Pharmacal Co., Inc.

Product
Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 503…
Reason
The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.
Published
December 28, 2016
Distribution
CA, FL, ID, IL, LA, MI, NC, NJ, NY, OH,…

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FDA Recall United States Terminated Historical recordClass III

Hi-Tech Pharmacal Co., Inc.

Product
Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 503…
Reason
Out-of-specification results for pH.
Published
December 28, 2016
Distribution
CA, FL, ID, IL, LA, MI, MN, NC, ND, NJ,…

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FDA Recall Terminated Historical recordClass II

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.

by Hi-Tech Pharmacal Co., Inc.

Reason
Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.
Published
November 5, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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.

by Hi-Tech Pharmacal Co., Inc.

Reason
Failed Stability Specification; product viscosity and or pH are below specification.
Published
January 1, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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

by Hi-Tech Pharmacal Co., Inc.

Reason
Subpotent; phenylephrine HCl
Published
October 30, 2013
Distribution
Puerto Rico

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FDA Recall Terminated Historical recordClass III

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.

by Hi-Tech Pharmacal Co., Inc.

Reason
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
Published
August 21, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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

by Hi-Tech Pharmacal Co., Inc.

Reason
Subpotent; 24 month stability test station
Published
June 26, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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

by Hi-Tech Pharmacal Co., Inc.

Reason
Subpotent; Cetylpyridinum Chloride
Published
May 22, 2013
Distribution
Puerto Rico

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FDA Recall Terminated Historical recordClass III

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.

by Hi-Tech Pharmacal Co., Inc.

Reason
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Published
May 8, 2013
Distribution
Nationwide

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Showing 1–9 of 9 results

This page lists recalls that name Hi-Tech Pharmacal Co., Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.