CLASS II Drug recall · Reported 7 Aug 2019 · FDA Enforcement Report
Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops recalled
ImprimisRx NJ is recalling Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, distributed nationwide in the US. The recall was initiated on 17 Jul 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1578-2019
- FDA event ID
- 83353
- Recalling firm
- ImprimisRx NJ, Ledgewood, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2019
- FDA classified
- 31 Jul 2019
- Reported
- 7 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 17 Jul 2019 | Recall initiated by company | |
| 31 Jul 2019 | Classified by FDA | +14 days |
| 7 Aug 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #:01252019@1, Exp. 07/21/2019; 03182019@7, Exp. 09/7/2019; 05092019@2, Exp. 11/2/2019
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 83353This product is part of a recall event; the main page for the event is Timolol- Dorzolamide- Latanoprost recalled by ImprimisRx NJ.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Timolol- Dorzolamide- Latanoprost recalled by ImprimisRx NJ | ImprimisRx NJ | Potency & Assay | Nationwide |
More recalls from ImprimisRx NJ
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic recalled | ImprimisRx NJ | Potency & Assay | Nationwide |
| Drug | CLASS II | Timolol-Latanoprost (0.5/0.005%) ophthalmic drops recalled | ImprimisRx NJ | Potency & Assay | Nationwide |
| Drug | CLASS II | Timolol- Dorzolamide- Latanoprost recalled by ImprimisRx NJ | ImprimisRx NJ | Potency & Assay | Nationwide |