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SafetyAlerts
August 28, 2002

AmeriSource Has Recalled Proventil and Theo-Dur

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

PRODUCT
a) Proventil brand of (albuterol sulfate, USP) Repetabs brand of
extended-release Tablets, 4 mg, bottles of 100, Rx only.
Recall # D-330-2;
b) Theo-Dur (THEOPHYLLINE(Anhydrous), Extended-Release Tablets 200 mg,
bottles of 100 and 500, Rx only. Recall # D-331-2.

CODE
a) PROVENTIL
Lot Number Exp Date
15920 APR 02
16224 APR 02
16678 MAY 02
16745 MAY 02
010804 JUL 02

b) THEO-DUR
Lot Number Exp Date
16924 MAY 02
16228B MAY 02
16228A MAY 02
16411 MAY 02

RECALLING FIRM/MANUFACTURER
Recalling Firm: AmeriSource Health Services Corp., Columbus, OH, by letter and fax on June 4, 2002.
Manufacturer: Schering Corp., Kenilworth, NJ. Firm initiated recall is ongoing.

REASON
Dissolution; failures at the sixth and eighth hour (stability) by
manufacturer.

VOLUME OF PRODUCT IN COMMERCE
8,406 bottles (Proventil); and 3,318 bottles (Theo-Dur).

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?

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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.