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
Reported: November 18, 2020 Initiated: October 30, 2020 #D-0070-2021
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
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- AVKARE Inc.
- Units Affected
- 15,678 bottles
- Distribution
- Nationwide
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by AVKARE Inc.. Units affected: 15,678 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 18, 2020. Severity: Moderate. Recall number: D-0070-2021.
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