The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1048-2018·Announced 2018-08-15

Longbow Recalls Emergency First Aid Eyewash Due to Manufacturing Deviations

Longbow First Aid Products Manufactory is recalling 30,000 bottles of Emergency First Aid Eyewash due to CGMP deviations. The product was distributed in New York and California.

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. According to the rubric, FDA Class II recalls with potential for serious injury or hospitalization are rated as Severe (4).

Plain-English summary

Longbow First Aid Products Manufactory is voluntarily recalling 30,000 bottles of Emergency First Aid Eyewash (Purified Water 98.3%). The product is packaged in 4 fl oz (118 ml) and 0.67 fl oz (20 ml) bottles and was manufactured for Redicare LLC in Congers, NY. The recall was initiated on July 17, 2018, and is classified as FDA Class II.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The affected product includes Lot # 20171210 with an expiration date of 12/2022. The recall covers two NDC codes: 711050002 and 71150000.

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 was terminated on September 11, 2019.

The recalled product

Product
Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NY
Manufacturer
Longbow First Aid Products Manufactory
Category
Drug — First Aid / Ophthalmic
Hazard
Affected units
30,000

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 (3)

  • Lot #: a) 20171210
  • Exp. 12/2022
  • b) 20171210

Distribution

Distributed in 2 states:

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 →

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