FDA-Drug2014-11-26Class II
Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121
Prometheus Laboratories Inc.
Hazard
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Sold states
Nationwide
Affected count
16,296 bottles (60-count), 5,166 bottles (250-count)
Manufactured in
9410 Carroll Park Dr, N/A, San Diego, CA, United States
Products
Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0249-2015Don't want to check this manually?
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