Recalls / Class II
Class IID-1485-2019
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
- Affected lot / code info
- 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.
Why it was recalled
Lack of Assurance of Sterility.
Recalling firm
- Firm
- First Pharma Associates LLC dba Riverpoint Pharmacy
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 1802 N Monroe St, Spokane, Washington 99205-4528
Distribution
- Quantity
- a) 60 EA, b) 15mL, c) 24 EA
- Distribution pattern
- ID, WA only
Timeline
- Recall initiated
- 2019-06-26
- FDA classified
- 2019-07-11
- Posted by FDA
- 2019-07-17
- Terminated
- 2023-06-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1485-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.