Drug product
CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
D-1026-2016
Product summary
- Event
- Event 74187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 916 total
- Official record key
drug-enforcement:D-1026-2016
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Code information: Lot #:01082016:75@3, Exp.07/06/2016; Lot #:01282016:72@10, Exp. 07/27/2016; Lot #: 02012016:74@35, Exp. 07/31/2016; Lot #:02102016:40@16, Exp.08/09/2016; Lot #: 02242016:73@41, Exp. 08/23/2016; Lot #: 03102016:64@53, Exp.09/07/2016; Lot #:04052016:70@16 Exp. 10/02/2016; Lot #: 04222016:85@37, Exp.10/22/2016.
Distribution pattern: NV
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility