Drug product
HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01.
D-0648-2022
Product summary
- Event
- Event 89591
- Status
- Terminated
- Classification
- Class I
- Quantity
- 115 vials
- Official record key
drug-enforcement:D-0648-2022
Official wording
Reason: Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Code information: Lot: 631359 BUD: 05/01/2022
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Microbial contamination
bacterial contamination