CLASS II Drug recall · Reported 21 Aug 2013 · FDA Enforcement Report
Cyclosporine Ophthalmic, compounded by Pallimed Solutions recalled
Pallimed Solutions is recalling Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA, distributed nationwide in the US. The recall was initiated on 25 Mar 2013 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-864-2013
- FDA event ID
- 64716
- Recalling firm
- Pallimed Solutions, Woburn, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Mar 2013
- FDA classified
- 9 Aug 2013
- Reported
- 21 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 25 Mar 2013 | Recall initiated by company | |
| 9 Aug 2013 | Classified by FDA | +137 days |
| 21 Aug 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Which lots are affected?
All lots within expiry
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 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
24 other products · FDA event 64716This product is part of a recall event; the main page for the event is HCG Chorionic Gonadotropin, compounded by Pallimed recalled.
More recalls from Pallimed Solutions
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydroxyprogesterone CAPR.(G.S.) recalled by Pallimed Solutions | Pallimed Solutions | Sterility | Nationwide |
| Drug | CLASS II | MIC with B6 and B12, compounded by Pallimed Solutions recalled | Pallimed Solutions | Sterility | Nationwide |
| Drug | CLASS II | Diazepam Injectable, compounded by Pallimed Solutions recalled | Pallimed Solutions | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/Testosterone Enanthate Injection recalled | Pallimed Solutions | Sterility | Nationwide |
| Drug | CLASS II | Atropine Injection, compounded by Pallimed Solutions recalled | Pallimed Solutions | Sterility | Nationwide |
Other Cyclosporine recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalledCequa | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Neoral soft gelatin capsules (cyclosporine capsules recalledNeoral | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) recalledCequa | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalledCequa | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalledCequa | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |