RecallRadar

FDA Drug recall D-1094-2017

Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc

On 2017-08-23 the FDA classified a Class III recall of Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc by Avkare, citing failed impurities/degradation specifications: Out of specification for a related compound C.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1094-2017
ClassificationClass III
Statusterminated
Initiated2017-07-19
Published2017-08-23
Last updated2026-09-13 11:51 UTC
CompanyAvkare
DistributionUS

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

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

Identifiers

code_infoLot #: 16933, Exp 07/2018; 17054, Exp 08/2018

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1094-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.