The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1128-2019·Announced 2019-04-24

MSM Red Eye Eye Drops Recalled for Sterility Assurance Issues

MSM Nutraceuticals is recalling Red Eye Eye Drops because the product lacks assurance of sterility 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an ophthalmic product is a significant hazard that fits the Class II criteria for a higher severity rating than a minor labeling error.

Plain-English summary

MSM Nutraceuticals, LLC is recalling 200 15 ml bottles of Red Eye Eye Drops. The product contains OptiMSM, Glycerin USP, Hyaluronic Acid, and Naphazolene Chloride. The recall is limited to Lot # 1808051 with an expiration date of 01/01/22.

The FDA has classified this as a Class II recall due to a lack of assurance of sterility. The source text states that the product is not terminally sterilized and was not tested per USP 71. This defect poses a potential risk of infection or other adverse health consequences if the product is used.

The product was distributed nationwide in the USA. Consumers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recall details, consumers should stop using it and contact the manufacturer for instructions on return or disposal.

The recalled product

Product
Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufactured by: MSM Nutraceuticals, LLC , UPC 8 54582 00118 0
Manufacturer
MSM Nutraceuticals, LLC
Category
Drug — Ophthalmic
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 # 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 →

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