Drug product
C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
D-0017-2020
Product summary
- Event
- Event 83427
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 syringes
- Official record key
drug-enforcement:D-0017-2020
Official wording
Reason: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Code information: Lot #: 070919C, BUD 08/23/19
Distribution pattern: Patient Specific Prescriptions in NJ
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility