Why it was recalled
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Product description
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
Lot numbers, UPCs & expiration codes
Lot: 38617 Exp. 10/2022
Where it was sold
Distributed in Los Angeles California
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-0631-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 9, 2021
- FDA report date
- Jun 23, 2021
- Quantity
- 10 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-0631-2021, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 88091
- Address
- 615 N 1st St
- Code information
- Lot: 38617 Exp. 10/2022
- Postal code
- 38478-2403
- Report date
- Jun 23, 2021
- Product type
- Drugs
- Recall number
- D-0631-2021
- Classification
- Class III
- Recalling firm
- AVKARE Inc.
- Product quantity
- 10 cartons
- Termination date
- Jun 2, 2023
- Reason for recall
- Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
- Distribution pattern
- Distributed in Los Angeles California
- Recall initiation date
- Jun 9, 2021
- Initial firm notification
- Letter
- Center classification date
- Jun 16, 2021