Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
Summary
The FDA issued a Class II for Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Impr by ImprimisRx NJ. Reason: Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost..
Details
Source
Drug Recall
External ID
D-0060-2023
Action Date
2022-11-23
Status
Terminated
Category
drug
Product Description
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
Lot/Code Info: Lot # 06272022@3, Exp. date 11/24/2022 Lot # 08302022@1, Exp. date 01/27/2023
Quantity Affected: 960 bottles
Reason for Recall
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-09
Company
Ledgewood, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 23 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ImprimisRx NJ) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ImprimisRx NJ have FDA actions?
This is the only FDA action we have on record for ImprimisRx NJ in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0060-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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