September 2013 FDA Recall Drug by Hi-tech Pharmacal Co., Inc.
D-66207-001 - Subpotent; phenylephrine HCl

This Class III drug recall was voluntarily initiated by Hi-tech Pharmacal Co., Inc. on September 4, 2013 for the product Drug. The FDA reported the reason for recall as subpotent; phenylephrine hcl. The product was distributed in Puerto Rico and the recall is currently terminated.

Recall Number: D-66207-001

Reason for Recall
Subpotent; phenylephrine HCl
Initiated
09-04-2013
Reported
10-30-2013
Quantity
50,848 bottles (total for 3 lots)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66207
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hi-Tech Pharmacal Co., Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-29-2015
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# 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).