Drug product
C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
D-0003-2020
Product summary
- Event
- Event 83427
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 droptainer bottles
- Official record key
drug-enforcement:D-0003-2020
Official wording
Reason: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Code information: Lot #: a) 070819A, BUD 08/22/19; b) 071619F, BUD 08/30/19
Distribution pattern: Patient Specific Prescriptions in NJ
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility