Home / Recalls / Hi-Tech Pharmacal Co., Inc. / D-66207-001

D-66207-001 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
October 30, 2013
Initiation Date
September 4, 2013
Termination Date
April 29, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
50,848 bottles (total for 3 lots)

Product Description

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

Reason for Recall

Subpotent; phenylephrine HCl

Distribution Pattern

Puerto Rico

Code Information

1 fl. oz. and 8 fl. oz.: Batch/Lot 615688 (exp. 06/2014) and Batch/Lot 617689 (exp. 11/2014); 16 fl. oz: Batch/Lot 615649 (exp. 05/2014).

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-888-2013 Class III — Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL la (July 25, 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)