D-0476-2024 Class II Ongoing

Recalled by Imprimis NJOF, LLC — Ledgewood, NJ

FDA drug recall D-0476-2024 was initiated by Imprimis NJOF, LLC on April 10, 2024 and is designated Class II. Reason for recall: Subpotent Drug The recall status is ongoing. Affected quantity: 3320 bottles.

Recall Details

Product Type
Drugs
Report Date
May 8, 2024
Initiation Date
April 10, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3320 bottles

Product Description

Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08

Reason for Recall

Subpotent Drug

Distribution Pattern

U.S. Nationwide

Code Information

Lot #: 23JUN031; Exp. 07/03/2024