Drug product
Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.
D-1447-2016
Product summary
- Firm
- Medicap Pharmacy
- Event
- Event 74725
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 bottle
- Official record key
drug-enforcement:D-1447-2016
Official wording
Reason: Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.
Code information: Lot #: 05092016@19, Beyond Use Date: 06/08/16; Discard After 09/01/2017.
Distribution pattern: ID
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility