FDA-Drug2020-11-18Class II
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
AVKARE Inc.
Hazard
Failed Dissolution Specifications
Sold states
Nationwide
Affected count
15,678 bottles
Manufactured in
615 N 1st St, Pulaski, TN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0070-2021Don't want to check this manually?
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