MSM Eye Drops Recalled for Lack of Sterility Assurance
MSM Nutraceuticals is recalling 15% MSM Eye Drops because the product is not terminally sterilized and was not tested per USP 71.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While specific injury reports are not detailed in the text, the lack of sterility assurance in eye drops presents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious injury.
Plain-English summary
MSM Nutraceuticals, LLC is recalling 5,000 bottles of 15% MSM Eye Drops (30 ml) due to a lack of assurance of sterility. The product was not terminally sterilized and was not tested according to USP 71 standards. The recalled items are identified by Lot # 1808051 and have an expiration date of 01/01/22.
The recall is classified as FDA Class II. The affected product was distributed nationwide in the USA. Consumers should check their inventory for the specific lot number and expiration date listed above.
Individuals who have used the product should consult a healthcare professional if they experience any adverse effects. The recall is being conducted to ensure product safety and compliance with sterility standards.
The recalled product
- Product
- 15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107, Phoenix, AZ 85027, UPC 8 54582 00120 3.
- 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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