Longbow Eyewash Solution Recalled for CGMP Deviations
Longbow First Aid Products Manufactory is voluntarily recalling 14,400 bottles of Eyewash Purified water 98.3% Ophthalmic Solution due to CGMP deviations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a reasonable probability of temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses or injuries, and the hazard is related to manufacturing deviations rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
Longbow First Aid Products Manufactory is voluntarily recalling 14,400 bottles of Eyewash Purified water 98.3% Ophthalmic Solution. The product is packaged in 4 FL OZ and 8 FL OZ bottles. The recall was initiated on July 17, 2018, and was classified as Class II by the FDA.
The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The affected lots are 20171215 and 20171016 for the 4 FL OZ bottles, and 20171016 for the 8 FL OZ bottles. The product was distributed in New York and California.
Consumers who have this product should stop using it and contact the recalling firm for instructions. The recall status is terminated as of September 11, 2019.
The recalled product
- Product
- Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211.
- Manufacturer
- Longbow First Aid Products Manufactory
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 14,400
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 #: a) 20171215 and 20171016
- b) 20171016
Distribution
Part of a larger recall action
This product is one of 2 recalled by Longbow First Aid Products Manufactory 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 2 products in this recall →Related recalls
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