Reported Oct 21, 2015 · Terminated
Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt 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?
- Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015
- Lot codes and dates
- Batch Numbers
a) 2625093Exp 6/30/20162617893Exp 5/31/201626581372658140Exp 11/30/20162644265Exp 9/30/2016 b) 254448625444872544488Exp 7/31/2016260012526001262600127Exp 2/29/2016264427226442732644265Exp 9/30/201626250922625093Exp 6/30/2016265813726581382658140 Exp 11/30/20162610783Exp 4/30/20162617891Exp 5/31/2016
- Batch Numbers
- Amount recalled
- 329,748 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.
Want the full recall guide?
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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