Reported Oct 21, 2015 · Terminated
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC…
Ohm Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ohm Laboratories, Inc. · 1385 Livingston Ave · North Brunswick, NJ · 08902-1829
Is this the product you have?
- 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.
- Lot codes and dates
- Batch Numbers
a) 2600127Exp 2/29/20162617892Exp 5/31/201626442659/30/20162625092Exp6/30/20162658140Exp 11/30/2016. b) 2617892Exp 5/31/201626107834/30/20162644272Exp 9/30/2016
- Batch Numbers
- Amount recalled
- 53,688 boxes
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Superpotent Drug: Out Of Specification (OOS) result for Assay.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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