Agency classClass IIOur severity:High FDA (Drugs)·D-1485-2019·Announced 2019-07-17

Riverpoint Pharmacy Recalls Serum Tears 20% Eye Drops Due to Sterility Concerns

First Pharma Associates is recalling specific lots of Serum Tears 20% Eye Drops in Idaho and Washington due to a lack of assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

First Pharma Associates LLC, doing business as Riverpoint Pharmacy, is recalling specific lots of Serum Tears 20% Eye Drops PF Solution. The recall is due to a lack of assurance of sterility in the product. The affected product is packaged in 15 mL vials and 12 EA units and is available by prescription only.

The recall covers specific lot numbers with expiration dates ranging from July 2019 to December 2019. The product was distributed only in Idaho and Washington. The source text does not report any illnesses or injuries associated with this recall.

Consumers with the affected product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.

The recalled product

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
Manufacturer: First Pharma Associates LLC dba Riverpoint Pharmacy
Category: Drug — Ophthalmic
Hazard: sterility

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

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

Distributed in 2 states:

Part of a larger recall action

This product is one of 18 recalled by First Pharma Associates LLC dba Riverpoint Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 18 products in this recall →

Same manufacturer · First Pharma Associates LLC dba Riverpoint Pharmacy

See all →

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High
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FDA (Drugs) · 2019-07-17
Severe
Riverpoint Pharmacy Recalls Testosterone Cyp/Estradiol Cyp Injection Due to Sterility Concerns
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Same hazard · sterility