Recalls / Class III
Class IIID-1094-2017
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
- Affected lot / code info
- Lot #: 16933, Exp 07/2018; 17054, Exp 08/2018
Why it was recalled
Failed impurities/degradation specifications: Out of specification for a related compound C.
Recalling firm
- Firm
- AVKARE Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 1172 cartons (23440 tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-07-19
- FDA classified
- 2017-08-15
- Posted by FDA
- 2017-08-23
- Terminated
- 2019-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1094-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.