Class II · Moderate risk Ongoing
Thymosin Beta-4
Reason Lack of Assurance of Sterility
Halobetasol Propionate Ointment 0.05% Net Wt.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
What was recalled
Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67
- Recalling firm
- McKesson Corporation dba McKesson Drug Company
- NDC code
- 63739-998-67
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0847-2022
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
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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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