D-0416-2025 Class II Ongoing
FDA drug recall D-0416-2025 was initiated by BSO LLC on April 28, 2025 and is designated Class II. Reason for recall: Presence of Particulate Matter: Glass particles were found in pellet vials. The recall status is ongoing. Affected quantity: 1,964 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 14, 2025
- Initiation Date
- April 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,964 vials
Product Description
TESTOSTERONE PELLET 200 mg BLUNT, 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: 70168-0121-01
Reason for Recall
Presence of Particulate Matter: Glass particles were found in pellet vials.
Distribution Pattern
Nationwide in the USA
Code Information
Lot 20250129@1, exp 1/17/2026; Lot 20250218@4, exp 1/25/2026