Drug product
BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
D-1196-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 180 vials
- Official record key
drug-enforcement:D-1196-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch #: 11022106A1, Exp 4/30/2022; 11192106A2, Exp 5/18/2022; 12022105A1, Exp 5/31/2022; 12132108A1, Exp 6/11/2022; 12292117A1, Exp 6/27/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility