Drug product
Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47
D-0787-2016
Product summary
- Event
- Event 73336
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 bottles
- Official record key
drug-enforcement:D-0787-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 012516, 020516
Distribution pattern: PA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility