Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences

spacer.gif (43 bytes)

FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 3, 1999

PRODUCT
Nalex DH, Rx antitussive and decongestant, (Hydrocodone Bitartrate 1.67 mg/5mL/Phenylephrine Hydrochloride 5 mg/5mL), in 16 fluid ounce bottles, distributed by Blansett Pharmacal Co., Inc., (BPCI). NDC #51674-0005-7. Recall #D-125-9.

CODE
Lot #91638 EXP 10/2000.

MANUFACTURER
Great Southern Laboratories (GSL), Houston, Texas.

RECALLED BY
Manufacturer, by letter dated February 2, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
6,506 bottles were distributed.

REASON
Mislabeling - Some bottles have the incorrect (Nalex A) insert attached.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.