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

SafetyAlerts
November 15, 2001

Thames Pharmacal Recalls Fluocinolone Acetonide Topical Solution

Ronkonkoma, NY  (SafetyAlerts) - The Food and Drug Administration (FDA) said that Thames Pharmacal is recalling Fluocinolone Acetonide Topical Solution, USP, 0.01%, For External Use Only, Not for Ophthalmic Use, Rx only,20 mL and 60 mL plastic bottles.

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

PRODUCT
Fluocinolone Acetonide Topical Solution, USP, 0.01%, For External Use Only, Not for Ophthalmic Use, Rx only,20 mL and 60 mL plastic bottles.

The Thames brand 20 mL bottle has a white and blue colored label, and is labeled in part, "xxx NDC 49158-209-40 xxx FLUOCINOLONE ACETONIDE xxx SOLUTION xxx USP, 0.01% xxx Rx only xxx 20 mL xxx Thames PHARMACAL CO., INC. xxx Ronkonkoma, N.Y. 11779 USA xxx".

The Thames brand 60 mL bottle is white and blue colored label, and is labeled in part, "xxx NDC 49158-209-32 xxx FLUOCINOLONE ACETONIDE xxx SOLUTION USP, 0.01% xxx Rx only xxx 60 mL xxx Thames PHARMACAL CO., INC. xxx Ronkonkoma, N.Y. 11779 USA xxx".

The Qualitest brand 20 mL bottle has a brown and beige colored label, and is labeled in part, "xxx NDC 0603-1231-43 xxx FLUOCINOLONE ACETONIDE xxx TOPICAL SOLUTION USP, 0.01% xxx Mfg. for: QUALITEST PHARMACEUTICALS, INC., xxx HUNTSVILLE, AL 35811 xxx Rx only xxx NET CONTENTS 20 mL xxx Qualitest(R) xxx".

The Qualitest brand 60 mL bottle has a brown and beige colored label, and is labeled in part, "xxx NDC 0603-1231-49 xxx FLUOCINOLONE ACETONIDE xxx SOLUTION USP, 0.01% xxx Mfg. for: QUALITEST PHARMACEUTICALS, INC., xxx HUNTSVILLE, AL 35811 xxx NET CONTENTS 60 mL xxx Qualitest(R) xxx".

The Schein Pharmaceutical brand 60-mL bottle has blue and white colored label, and is labeled in part, ?xxx SCHEIN PHARMACEUTICAL xxx NDC 0364-7343-58 xxx FLUOCINOLONE ACETONIDE xxx Topical Solution, USP, xxx 0.01% xxx Mfd. for: Schein Pharmaceutical, Inc. xxx Florham Park, NJ 07932 USA xxx 60 mL xxx?.

The Major Pharmaceuticals brand 60-mL bottle has a blue, red and green colored label, and is labeled in part, ?xxx NDC 0904-2661-03 xxx Fluocinolone Acetonide xxx Topical Solution USP, xxx 0.01% xxx Rx only xxx 60 mL xxx MAJOR(R) PHARMACEUTICALS xxx Distributed by Major Pharmaceuticals xxx Livonia, MI 48150 USA xxx?.

Recall #D-024-2

CODE
Lots: N304 (exp. 7/2002), N409 (exp. 7/2002), N588 (exp. 12/2002), N660 (exp. 2/2003) Thames NDC: 49158-209-40 (20 mL), 49158-209-32 (60 mL)Qualitest NDC: 0603-1231-43 (20 mL), 0603-1231-49 (60 mL) Schein NDC: 0364-7343-58 (60 mL). Major NDC: 0904-2661-03 (60 mL).
 

PLEASE NOTE: Schein Pharmaceutical labeled product in 20 mL bottles with NDC 0364-7343-55 listed in the 24 Hour Alert was not included in the RR as it was discovered that it had not been distributed.

RECALLING FIRM/MANUFACTURER
Thames Pharmacal Co., Inc. Ronkonkoma, NY, by letter, dated 10/3/01. Firm initiated recall is ongoing.

REASON
Subpotency (12 month stability).

VOLUME OF PRODUCT IN COMMERCE
A total of 73,612 bottles: 37,696 - 20 mL bottles and 35,916 - 60 mL bottles.

DISTRIBUTION
Nationwide and Puerto Rico
.

 
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.