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

SafetyAlerts
October 18, 2001

Able Laboratories Recalls Nitro Tab (Nitroglycerin Tablets, USP)

South Plainfield, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said that Able Laboratories is recalling Nitro Tab (Nitroglycerin Tablets, USP) 0.3mg (1/200 gr), Rx Only, 100 Sublingual tablets, Lot 021002, bottles of 100's.

This is the first public notice of this Class lI recall issued by the FDA.

RECALL NUMBER, PRODUCT AND CODE:
D-309-1, Nitro Tab (Nitroglycerin Tablets, USP) 0.3mg (1/200 gr), Rx Only, 100 Sublingual tablets, Lot 021002, bottles of 100's.

Codes:
Lot 012002, Exp. 12/2002.

REASON:
Mislabeled: 0.3 MG Product Labeling (Exterior Carton ) incorrectly declares bottles to contain 0.4 MG. tablets.

MANUFACTURER/RECALLING FIRM:
Able Laboratories, South Plainfield, NJ

RECALLED BY:
Manufacturer, by letter dated 8/27/2001

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
OH

QUANTITY:
1260/100 tablet bottles.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

Sign-up for SafetyAlerts by Email -
The free internet newsletter that could
some day literally save your life - or
the life of someone you know.

 

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.