Multi-event July 2018 FDA Recall Drug by Longbow First Aid Products Manufactory

This Multi-event Class II drug recall was voluntarily initiated by Longbow First Aid Products Manufactory on July 17, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in NY and CA. and the recall is currently terminated.

Reported Recall Events

D-1049-2018 TERMINATED D-1048-2018 TERMINATED

Recall Number: D-1049-2018

Reason for Recall
CGMP Deviations
Initiated
07-17-2018
Reported
08-15-2018
Quantity
14,400 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80614
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Longbow First Aid Products Manufactory
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NY and CA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2019
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : a) 20171215 and 20171016, b) 20171016

Recall Number: D-1048-2018

Reason for Recall
CGMP Deviations
Initiated
07-17-2018
Reported
08-15-2018
Quantity
30,000 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80614
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Longbow First Aid Products Manufactory
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NY and CA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2019
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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