Drug product
SERMORELIN ACETATE 10 MG INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
D-997-2013
Product summary
- Event
- Event 65876
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-997-2013
Official wording
Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Code information: 03182013@6, 03282013@26,01142013@2, 01182013@2, 01172013@15, 02192013@3, 03062013@8, 04102013@3, 04262013@11, 05142013@35, 05212013@20, 5212013@17, 05242013@6, 06082013@3, 06072013@10, 06182013@27, 06292013@1, 07132013@2, 07232013@3, 03182013@14
Distribution pattern: USA nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility