Drug product
GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
D-0985-2016
Product summary
- Event
- Event 74187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 869 Units (Total All Products)
- Official record key
drug-enforcement:D-0985-2016
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Code information: Lot #: 01182016:29@27 , Exp. 02/01/2016; Lot #: 030720 1631@50, Exp. 03/21/2016; Lot #: 03232016:83@6, Exp 04/06/2016; Lot #: 03282016:43@11, Exp. 04/11/2016; Lot #: 04192016:43@16, Exp. 05/03/2016
Distribution pattern: NV
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility