Drug product
Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made Compounding
D-1212-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 182 vials
- Official record key
drug-enforcement:D-1212-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch #: a) 01072212A1, Exp 4/7/2022; 03032220A1, Exp 6/1/2022; b) 12162120A2, Exp 3/16/2022; 01142205A1, Exp 4/14/2022; 02012226A1, Exp 5/2/2022; 03032220A1, Exp 6/1/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility