Why it was recalled
Failed Dissolution Specifications
Product description
Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12
Lot numbers, UPCs & expiration codes
Lots: 26085 Exp. 07/2021, 26426 Exp. 01/2022, 26983 Exp. 04/2022, 28647 Exp. 06/2022
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-0070-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 30, 2020
- FDA report date
- Nov 18, 2020
- Quantity
- 15,678 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-0070-2021, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 86695
- Address
- 615 N 1st St
- Code information
- Lots: 26085 Exp. 07/2021, 26426 Exp. 01/2022, 26983 Exp. 04/2022, 28647 Exp. 06/2022
- Postal code
- 38478-2403
- Report date
- Nov 18, 2020
- Product type
- Drugs
- Recall number
- D-0070-2021
- Classification
- Class II
- Recalling firm
- AVKARE Inc.
- Product quantity
- 15,678 bottles
- Termination date
- Jun 2, 2023
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 30, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 6, 2020