Class II · Moderate risk Ongoing
Thymosin Beta-4
Reason Lack of Assurance of Sterility
Zebeta¿
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications: OOS result during stability testing
What was recalled
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
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 51285-061-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1112-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Beta recalls
See all
Class II · Moderate risk Ongoing
BPC-157/Thymosin Beta-4 for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Labetalol Hydrochloride Injection
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk Terminated
labetalol HCl 20 mg/4mL Injection
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
Betaxolol Tablets
Reason Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
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