FDA Drug Recalls

Recalls / Class III

Class IIID-0387-2021

Product

Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Manufactured by: Nomax, Inc, St. Louis, MO 63123, NDC: 51801-008-15

Brand name
Dry Eye Test
Generic name
Fluorescein Sodium
Active ingredient
Fluorescein Sodium
Route
Ophthalmic
NDC
51801-008
Affected lot / code info
LOT 13336 EXP 07/23

Why it was recalled

Subpotent Drug

Recalling firm

Firm
Nomax Inc
Manufacturer
Nomax Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
9735 Green Park Industrial Dr, N/A, Saint Louis, Missouri 63123-7241

Distribution

Quantity
78 cartons
Distribution pattern
Nationwide USA

Timeline

Recall initiated
2021-04-13
FDA classified
2021-05-18
Posted by FDA
2021-05-26
Terminated
2023-09-28
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0387-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: Dry Eye Test · FDA Drug Recalls