MSM Nutraceuticals Recalls Dry Eye Eye Drops for Sterility Concerns
MSM Nutraceuticals is recalling Dry Eye Eye Drops because the product was not terminally sterilized and was not tested per USP 71.
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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility failures in eye drops) are categorized as Severe.
Plain-English summary
MSM Nutraceuticals, LLC is recalling 200 bottles of Dry Eye Eye Drops (15ml each) due to a lack of assurance of sterility. The product contains OptiMSM, Glycerin USP, Hyaluronic Acid, and Polyethylene Glycon. The affected lot number is 1808051, with an expiration date of 01/01/22. The product was distributed nationwide in the USA.
The recall was initiated because the product is not terminally sterilized and was not tested per USP 71 standards. This classification indicates a potential risk of contamination, although the source text does not specify reported illnesses or injuries.
Consumers who have purchased this product should stop using it and contact MSM Nutraceuticals, LLC for further instructions or a refund. The recall is classified as FDA Class II, which suggests a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51 fl oz., Manufactured by: MSM Nutraceuticals, LLC, UPC 8 54582 00119 7.
- Manufacturer
- MSM Nutraceuticals, LLC
- Category
- Drug — Ophthalmic
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 # 1808051
- Exp. Date 01/01/22
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by MSM Nutraceuticals, LLC 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 4 products in this recall →Related recalls
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