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August 23, 2001

Roxane Laboratories Inc. Recalls Alupent and Metaproterenol Sulfate Inhalation Solution

Columbus, OH (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Roxane Laboratories Inc. is recalling Alupent and Metaproterenol Sulfate Inhalation Solution because of a lack of assurance of sterility (CGMP Deviations).

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

RECALL NUMBER, PRODUCT AND CODE:
1) D-285-1, Alupent (metaproterenol sulfate USP) Inhalation Solution, 0.4% (10mg/vial)

2) D-286-1, Alupent (metaproterenol sulfate USP) Inhalation Solution, 0.6% (15mg/vial); The manufacturer's brand name product is packaged in 25 X 2.5 ml Unit-Dose Vials, under the Boegringer Ingelheim label, NDC #0597-0069-62.

3) D-286-1, Metaproterenol Sulfate Inhalation Solution USP, 0.6% (15mg/vial); The generic brand name product is packaged in 25 X 2.5 ml Unit-Dose Vials, under the Roxane Laboratories label, NDC #0054-8614-11.

CODE:
ALUPENT 0.4%:
Lot Number Exp Date
057144 Jul-02
780508 May-02
780507 Apr-02
780506 Mar-02
780505 Feb-02
780503 Dec-01
780502 Oct-01

ALUPENT 0.6%:
Lot Number Exp Date
690552 Nov-02
690551 Aug-02
699554 Oct-01

METAPROTERENOL SULFATE USP 0.6%:
Lot Number/ Exp Date

992862/ Oct-01

MANUFACTURER/RECALLING FIRM:
Roxane Laboratories Inc., Columbus, OH. This firm is part of the Boehringer Ingelheim Corporation

RECALLED BY:
Manufacturer by letter on 8/6/2001.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
OH, KY, AZ, CA, MA, MO, OR, FL, MA, NJ, MN, PA, AL, TX, CO, CT, ID, IL, LA, MS, NY, NC, SC, TN, UT, VA, WA, AK, WI, HI, and NM.

QUANTITY:
26,506 boxes / 25 vials each

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
Selected Recent Recalls


Health Professional:

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

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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.