Why it was recalled
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Product description
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
Lot numbers, UPCs & expiration codes
Lot #15152, Exp. 02/2018
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-0610-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 15, 2017
- FDA report date
- Mar 29, 2017
- Quantity
- 116 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-0610-2017, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 76617
- Address
- 615 N 1st St
- Code information
- Lot #15152, Exp. 02/2018
- Postal code
- 38478-2403
- Report date
- Mar 29, 2017
- Product type
- Drugs
- Recall number
- D-0610-2017
- Classification
- Class II
- Recalling firm
- AVKARE Inc.
- Product quantity
- 116 cartons
- Termination date
- Jun 1, 2022
- Reason for recall
- Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 15, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 22, 2017