CLASS II Drug recall · Reported 13 Sep 2017 · FDA Enforcement Report
Latanoprost PF Solution, 005%, Ophthalmic Drops in Sterile recalled
ImprimisRx CA, Inc is recalling Latanoprost PF Solution, 005%, Ophthalmic Drops in Sterile, Compounded for a licensed, distributed nationwide in the US. The recall was initiated on 23 Jun 2017 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-1131-2017
- FDA event ID
- 77647
- Recalling firm
- ImprimisRx CA, Inc, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jun 2017
- FDA classified
- 7 Sep 2017
- Reported
- 13 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Drug class
- Eye Drops
Timeline
| 23 Jun 2017 | Recall initiated by company | |
| 7 Sep 2017 | Classified by FDA | +76 days |
| 13 Sep 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Product as listed by the FDA
Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
Where it was distributed
Nationwide
Questions about this recall
Is Latanoprost PF Solution, 005%, Ophthalmic Drops in Sterile, Compounded for a licensed recalled?
Yes. ImprimisRx CA, Inc recalled Latanoprost PF Solution, 005%, Ophthalmic Drops in Sterile, Compounded for a licensed on 23 Jun 2017. The recall is Class II and its status is Terminated. Recall number D-1131-2017.
Why was it recalled?
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Which lots are affected?
0404017@32B, 10/01/2017
Where was it sold?
Nationwide
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from ImprimisRx CA, Inc
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Curcumin Emulsion 10mg/ml Injection recalled by ImprimisRx CA, Inc | ImprimisRx CA, Inc | Labeling Errors | Nationwide |
| Drug | CLASS II | Timolol-Brimonidine-Dorzolamide-Latanoprost recalled | ImprimisRx CA, Inc | Labeling Errors | Nationwide |
| Drug | CLASS II | Timolol-Latanoprost PF Solution 5-0.005)%, Ophthalmic Drops recalled | ImprimisRx CA, Inc | Labeling Errors | Nationwide |