Drug product
ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.
D-0309-2026
Product summary
- Event
- Event 98344
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 22,478 pellets.
- Official record key
drug-enforcement:D-0309-2026
Official wording
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Code information: Lot#: 253000117, Exp. 02/21/2026; 253000129, Exp. 06/12/2026; 253000130, Exp. 06/16/2026; 253000154, 253000155, Exp. 08/29/2026; 253000160, Exp. 09/10/2026.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign substance