ImprimisRx Recalls Subpotent Timolol-Dorzolamide-Latanoprost Ophthalmic Drops
ImprimisRx NJ is recalling 246 bottles of Timolol-Dorzolamide-Latanoprost ophthalmic drops because the medication was found to be subpotent.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the defect involves a subpotent drug which poses a significant risk of treatment failure.
Plain-English summary
ImprimisRx NJ is voluntarily recalling 246 bottles of Timolol-Dorzolamide-Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops. The product is packaged in 5mL bottles and is available by prescription only. The recall was initiated on July 17, 2019, and the FDA classified it as Class II.
The reason for the recall is that the drug was found to be subpotent, meaning it did not contain the full amount of the active ingredients required. The affected lots are 03132019@2 (expiration date 09/17/2019) and 05102019@2 (expiration date 11/02/2019). The product was distributed nationwide within the United States.
Patients who have this medication should contact their healthcare provider or pharmacist for guidance. The recall was terminated on April 22, 2020.
The recalled product
- Product
- Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
- Manufacturer
- ImprimisRx NJ
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 246
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 (4)
- Lot #: 03132019@2
- Exp. 09/17/2019
- 05102019@2
- Exp. 11/02/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by ImprimisRx NJ under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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