ImprimisRx Timolol-Latanoprost Ophthalmic Drops Recalled for Subpotent Active Ingredient
ImprimisRx is recalling 960 bottles of compounded Timolol-Latanoprost ophthalmic drops nationwide. Affected batches contain less than 90% of the labeled latanoprost amount.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a subpotent drug where no illnesses or injuries have been reported. The hazard is theoretical—underdosed medication poses a risk of treatment failure, but the source text contains no reported harm, placing this at the maximum of 3 per the rubric.
Plain-English summary
ImprimisRx NJ is recalling 960 bottles of Timolol-Latanoprost (0.5/0.005%) compounded ophthalmic drops in 5 mL bottles. The recall affects Lot # 06272022@3 (expiration 11/24/2022) and Lot # 08302022@1 (expiration 01/27/2023).
The recall was issued because the affected batches contain less than 90% of the labeled amount of latanoprost, the active ingredient. This subpotency means patients may not receive the full therapeutic dose of the medication.
The affected product was distributed nationwide in the USA. Patients using these eye drops should consult their eye care provider or pharmacist about whether their product is affected and what steps to take.
The recalled product
- Product
- Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
- Manufacturer
- ImprimisRx NJ
- Category
- Drug — Ophthalmic / Eye Drops
- Affected units
- 960
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # 06272022@3
- Exp. date 11/24/2022 Lot # 08302022@1
- Exp. date 01/27/2023
Distribution
Distributed nationwide across the United States.
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