CLASS II Drug recall · Reported 11 Jun 2014 · FDA Enforcement Report
Greenstone fluconazole for Oral Suspension, Orange Flavored recalled
Pfizer is recalling Greenstone fluconazole for Oral Suspension, Orange Flavored, 40 mg/mL, when reconstituted, distributed nationwide in the US. The recall was initiated on 29 Jan 2014 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-1356-2014
- FDA event ID
- 67532
- Recalling firm
- Pfizer, New York, NY
- Brand
- Fluconazole
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jan 2014
- FDA classified
- 30 May 2014
- Reported
- 11 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 29 Jan 2014 | Recall initiated by company | |
| 30 May 2014 | Classified by FDA | +121 days |
| 11 Jun 2014 | 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
Defective Container: Tamper evident ring failures discovered on some bottles.
Product as listed by the FDA
GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1
Where it was distributed
Nationwide, Italy and Republic of South Korea
Questions about this recall
Why was it recalled?
Defective Container: Tamper evident ring failures discovered on some bottles.
Which lots are affected?
Lot # A358502; Exp 01/15
Where was it sold?
Nationwide, Italy and Republic of South Korea
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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Other Fluconazole recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Potency & Assay | Nationwide |
| Drug | CLASS III | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Potency & Assay | Nationwide |
| Drug | CLASS III | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Packaging Defects | Nationwide |
| Drug | CLASS III | Fluconazole Injection, USP, 2 mg/mL, a) recalled by Renaissance Lakewood | Renaissance Lakewood | Potency & Assay | Nationwide |