Drug product
Serum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c) 12 EA, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252
D-1485-2019
Product summary
- Event
- Event 83253
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 60 EA, b) 15mL, c) 24 EA
- Official record key
drug-enforcement:D-1485-2019
Official wording
Reason: Lack of Assurance of Sterility.
Code information: Lot #: a) 06042019@20, Exp. 07/19/2019; 06052019@24, Exp. 07/28/2019; 06062019@10, Exp. 07/21/2019; b) 06132019@6, Exp. 07/29/2019; c) 06182019@28, Exp. 12/17/2019, 06192019@28, Exp. 12/18/2019.
Distribution pattern: ID, WA only
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility