FDAFDA · Food and drugs·Recall number D-0035-2016
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.
Published October 21, 2015 · Recall initiated: July 28, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug: Out Of Specification (OOS) result for Assay.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ohm Laboratories, Inc.
- Distributor
- Nationwide.
- Lot
- Batch Numbers: a) 2600127, Exp 2/29/2016; 2617892, Exp 5/31/2016; 2644265, 9/30/2016; 2625092, Exp, 6/30/2016; 2658140, Exp 11/30/2016. b) 2617892, Exp 5/31/2016; 2610783, 4/30/2016; 2644272, Exp 9/30/2016
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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