Drug Enforcement D-0060-2023

Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.

Status

Terminated

Classification

Class II

Report Date

November 23, 2022

Termination Date

August 23, 2023

Product Information

Product description
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
Product quantity
960 bottles
Reason for recall
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
ImprimisRx NJ
Address
1705 Us Highway 46 Ste 4, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0060-2023
Event ID
91140
Recall initiation date
November 9, 2022
Center classification date
November 14, 2022
Code info
Lot # 06272022@3, Exp. date 11/24/2022 Lot # 08302022@1, Exp. date 01/27/2023
More code info