FDA-Drug2015-06-10Class II

Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01

Teva Pharmaceuticals USA
Hazard

Failed Dissolution Specifications: OOS result during stability testing

Sold states
Nationwide
Affected count
889 bottles
Manufactured in
425 Privet Rd, N/A, Horsham, PA, United States
Products
Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1112-2015

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