Status
Ongoing
Drug Enforcement D-0412-2025
Presence of Particulate Matter: Glass particles were found in pellet vials.
Classification
Class II
Report Date
May 14, 2025
Termination Date
—
Product Information
- Product description
- TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-01
- Product quantity
- 2,762 vials
- Reason for recall
- Presence of Particulate Matter: Glass particles were found in pellet vials.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- BSO LLC
- Address
-
12860 W Cedar Dr Ste 211, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0412-2025
- Event ID
- 96792
- Recall initiation date
- April 28, 2025
- Center classification date
- May 6, 2025
- Code info
- Lot 20250102@6, exp 12/11/2025; Lot 20250130@4, exp 1/22/2026
- More code info
- —