Why it was recalled
Failed impurities/degradation specifications: Out of specification for a related compound C.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 16933, Exp 07/2018; 17054, Exp 08/2018
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1094-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 19, 2017
- FDA report date
- Aug 23, 2017
- Quantity
- 1172 cartons (23440 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-1094-2017, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 77800
- Address
- 615 N 1st St
- Code information
- Lot #: 16933, Exp 07/2018; 17054, Exp 08/2018
- Postal code
- 38478-2403
- Report date
- Aug 23, 2017
- Product type
- Drugs
- Recall number
- D-1094-2017
- Classification
- Class III
- Recalling firm
- AVKARE Inc.
- Product quantity
- 1172 cartons (23440 tablets)
- Termination date
- Mar 11, 2019
- Reason for recall
- Failed impurities/degradation specifications: Out of specification for a related compound C.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 19, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 15, 2017