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.