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

SafetyAlerts
August 28, 2002

King Pharmaceuticals Has Recalled Therevac

(SafetyAlerts) - The Food and Drug Administration (FDA) has released the following information.

PRODUCT
a) Therevac®-SB Mini Enema (Docusate Sodium 283 mg) Gelatin Ampules, unit
doses of 5 and 30 and bottles of 10 and 30. Recall # D-386-2;
b) Therevac-Plus Mini Enema w/Anesthetic, (Docusate Sodium 283 mg,
Benzocaine 20 mg) Gelatin Ampules, unit doses of 5 and 30 and bottles
of 50. Recall # D-387-2.
CODE
Therevac-SB
NDC Package Lot Number (Expiration)
52604-8317-00 1 X 5 Unit Dose K09002 (08/02), K11001 (09/02),
M02001 (12/02)
52604-8317-09 6 X 5 Unit Dose K09002 (08/02), K11001 (09.02),
M02001 (12/02), M06001 (04/03)
52604-8317-02 10 ct bottles K09001 (08/02), K09002 (08/02),
K11001 (09/02), K12001 (11/02),
K12002 (11/02), M06001 (04/03)
52604-8317-03 30 ct bottles K09001 (08/02), K09002 (08/02),
K11001 (09/02), K12001 (11/02),
K12002 (11/02), M01002 (11/02),
M02001 (12/02), M02002 (01/03),
M06001 (04/03)
Therevac-Plus
NDC Package Lot Number/Expiration
52604-8315-00 1 X 5 Unit Dose M01001 (12/02)
52604-8315-09 6 X 5 Unit Dose K10001 (08/02), M01001 (12/02),
M06002 (05/03), M10002 (09/03)
52604-8315-05 50 ct bottles K10001 (08/02), M01001 (12/02),
M01003 (11/03), M06002 (05/03).
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN, by letter on July 31, 2002.
Manufacturer: R. P. Scherer Laboratories, St. Petersburg, FL.
Firm initiated recall is ongoing.

REASON
Stability; product may not meet specifications throughout the labeled expiration date.

VOLUME OF PRODUCT IN COMMERCE
102,807.

DISTRIBUTION
Nationwide.
.

 
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.