Class II · Moderate risk Ongoing
Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason Lack of Assurance of Sterility
Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
What was recalled
Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only, Manufactured by SOFIE Co dba SOFIE, Dulles, VA 20166 for Life Molecular Imagining Ltd., NDC 54828-001-50
- Recalling firm
- Sofie Co dba Sofie
- NDC code
- 54828-001-50
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1177-2023
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, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock…
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk Terminated
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT…
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC#…
Reason Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
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