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

FDA recall notice · announced August 23, 2017 · Avkare

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Failed impurities/degradation specifications: Out of specification for a related compound C.

Notes

Distribution: Nationwide
Lot/code information: Lot #: 16933, Exp 07/2018; 17054, Exp 08/2018
Quantity: 1172 cartons (23440 tablets)
Status: Terminated
Products in this recall event:
- 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 (D-1094-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.