D-0476-2025 Class II Ongoing

Recalled by Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado) — Englewood, CO

FDA drug recall D-0476-2025 was initiated by Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado) on May 21, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 64 syringes.

Recall details

Product Type
Drugs
Report Date
Jul 2, 2025
Initiation Date
May 21, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
64 syringes

Product description

LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Reason for recall

Lack of Assurance of Sterility

Distribution pattern

USA Nationwide

Code information

Lot #: H277639, Exp 6/25/2025

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0476-2025
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-0476-2025. Report a data issue: hello@regdatalab.com.