Home / Recalls / Hi-Tech Pharmacal Co., Inc. / D-888-2013

D-888-2013 Class III Terminated

Recalled by Hi-Tech Pharmacal Co., Inc. — Amityville, NY

Recall Details

Product Type
Drugs
Report Date
August 21, 2013
Initiation Date
July 25, 2013
Termination Date
May 16, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
58,812 tubes

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Batch/Lot 619442, exp. 01/2015

Other recalls by Hi-Tech Pharmacal Co., Inc.

  • F-1380-2015 Class II — FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-T (December 23, 2014)
  • F-0820-2017 Class III — Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TEC (August 25, 2014)
  • F-0817-2017 Class III — Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TEC (July 28, 2014)
  • D-0048-2015 Class II — HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 (April 1, 2014)
  • D-389-2014 Class III — Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, (October 28, 2013)
  • D-66207-001 Class III — GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122 (September 4, 2013)
  • D-603-2013 Class III — HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), R (April 30, 2013)
  • D-418-2013 Class III — BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, (April 8, 2013)
  • D-302-2013 Class III — Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., In (March 11, 2013)