Red Mountain Compounding Recalls S-Ascorbic/Glutathione Ophthalmic Solution
Red Mountain Compounding Pharmacy is recalling S-Ascorbic/Glutathione 1.25/1.25% Ophthalmic Solution due to a lack of assurance of sterility.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score per the rubric, particularly given the risk of infection from non-sterile ophthalmic products.
Plain-English summary
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, is recalling S-Ascorbic/Glutathione 1.25/1.25% Ophthalmic Solution, 10ml dropper bottles. The recall is being conducted because the product lacks assurance of sterility.
The affected product is prescription-only and was distributed nationwide in the USA. The specific lot number is S07222019DH@09, with an expiration date of 8/22/19. The quantity involved is 2x 10 ml bottles.
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-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX
- Category
- Drug — Ophthalmic Solution
- 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 (2)
- Lot #: S07222019DH@09
- Exp 8/22/19
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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