CLASS III Drug recall · Reported 23 Aug 2017 · FDA Enforcement Report
Voriconazole Tablets, 200 mg cartons Dose recalled by AVKARE
AVKARE is recalling Voriconazole Tablets, 200 mg cartons Dose, distributed nationwide in the US. The recall was initiated on 19 Jul 2017 and the FDA has classified it as Class III.
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-1094-2017
- FDA event ID
- 77800
- Recalling firm
- AVKARE, Pulaski, TN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Jul 2017
- FDA classified
- 15 Aug 2017
- Reported
- 23 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 19 Jul 2017 | Recall initiated by company | |
| 15 Aug 2017 | Classified by FDA | +27 days |
| 23 Aug 2017 | Published in enforcement report | +8 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/degradation specifications: Out of specification for a related compound C.
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
Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12
Where it was distributed
Nationwide
Questions about this recall
Is Voriconazole Tablets, 200 mg cartons Dose recalled?
Yes. AVKARE recalled Voriconazole Tablets, 200 mg cartons Dose on 19 Jul 2017. The recall is Class III and its status is Terminated. Recall number D-1094-2017.
Why was it recalled?
Failed impurities/degradation specifications: Out of specification for a related compound C.
Which lots are affected?
Lot #: 16933, Exp 07/2018; 17054, Exp 08/2018
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 AVKARE
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|---|---|---|---|---|---|
| Drug | CLASS II | Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
Other Voriconazole recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Voriconazole Tablets 200 mg recalled by Glenmark PharmaceuticalsVoriconazole | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Voriconazole Tablets 50mg recalled by Glenmark PharmaceuticalsVoriconazole | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Voriconazole Tablets, 50 mg recalled by Amerisource Health ServicesVoriconazole | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Voriconazole for Oral Suspension, 40mg/mL recalledVoriconazole | Lupin Pharmaceuticals | Packaging Defects | IL, NJ, OH |
| Drug | CLASS II | Voriconazole Solution (1%(10 mg/mL) dropper recalled by US Compounding | US Compounding | Sterility | Nationwide |