Voriconazole Tablets recall: Impurity Out of Spec
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
Why was Voriconazole Tablets recalled?
Failed impurities/degradation specifications: Out of specification for a related compound C.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 16933, Exp 07/2018; 17054, Exp 08/2018
- Product
- 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
- Recalling firm
- AVKARE Inc.
- Quantity
- 1172 cartons (23440 tablets)
- Distribution
- Nationwide
- Recall date
- August 23, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)