The Recall Desk

FDA (Drugs) recall action 80614

Longbow First Aid Products Manufactory recalled 2 products on 2018-08-15

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-08-15
Critical
0
Units
44,400

Why these products were recalled

CGMP Deviations

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Drugs)··2018-08-15

    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.

    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.
    Category
    Distribution
    2 states
  • SevereFDA (Drugs)··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.

    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
    Category
    Distribution
    2 states