Why it was recalled
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Product description
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
Lot numbers, UPCs & expiration codes
Lot: 15270, Exp. 01/18
Where it was sold
Nationwide in the USA
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-0222-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 3, 2018
- FDA report date
- Jan 24, 2018
- Quantity
- 237 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-0222-2018, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 78867
- Address
- 615 N 1st St
- Code information
- Lot: 15270, Exp. 01/18
- Postal code
- 38478-2403
- Report date
- Jan 24, 2018
- Product type
- Drugs
- Recall number
- D-0222-2018
- Classification
- Class II
- Recalling firm
- AVKARE Inc.
- Product quantity
- 237 cartons
- Termination date
- May 8, 2020
- Reason for recall
- Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 3, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 12, 2018