FDA-Drug2015-10-21Class III
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.
Ohm Laboratories, Inc.
Hazard
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Sold states
Nationwide.
Affected count
53,688 boxes
Manufactured in
1385 Livingston Ave, N/A, North Brunswick, NJ, United States
Products
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0035-2016Don't want to check this manually?
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