Red Mountain Compounding Recalls S-Calcium Glucunate Opth Irrigation Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Calcium Glucunate 1% Opth Irrigation due to a lack of assurance of sterility. The product was distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a medical product, which aligns with the criteria for Severe severity.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Calcium Glucunate 1% Opth Irrigation, 50ml plastic containers. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is identified by Lot # S07162019DT@05 with an expiration date of 8/14/2019. The recall covers products distributed nationwide in the USA.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- S-CALCIUM GLUCONATE 1% OPTH IRRIGATION, 50ML plastic container, RX Only, Red Mountain Compounding RX
- Category
- Drug — Ophthalmic Irrigation
- Hazard
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 (1)
- Lot #: S07162019DT@05 exp: 8/14/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding 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.
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