CLASS II Drug recall · Reported 1 Mar 2017 · FDA Enforcement Report
CycloSPORINE Capsules, USP, 100 mg recalled by Apotex
Apotex is recalling CycloSPORINE Capsules, USP, 100 mg, distributed nationwide in the US. The recall was initiated on 3 Feb 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-0475-2017
- FDA event ID
- 76402
- Recalling firm
- Apotex, North York, N/A
- Brand
- Cyclosporine
- Manufacturer
- Apotex Corp.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Feb 2017
- FDA classified
- 23 Feb 2017
- Reported
- 1 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 3 Feb 2017 | Recall initiated by company | |
| 23 Feb 2017 | Classified by FDA | +20 days |
| 1 Mar 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
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
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
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0
Where it was distributed
Distributed Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Which lots are affected?
Lot MJ9837, Exp 07/2017. NDC 60505-0134-0, UPC 360505013401
Where was it sold?
Distributed 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.
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|---|---|---|---|---|---|
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled | Apotex | Potency & Assay | Nationwide |
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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 |