Reported Oct 21, 2015 · Terminated
CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged…
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?
- CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1
- Distributed byAmerican Sales Company, 4201 Walden Avenue, Lancaster, NY 14086
- Lot codes and dates
- Batch Numbers
(a) 2617891Exp 5/31/20162600127Exp 2/29/20162544487Exp 7/31/20152610783Exp 4/30/2016 (b) 2600127Exp 2/29/20162544487Exp 7/31/20152617891Exp 5/31/20162644272Exp 9/30/2016
- Batch Numbers
- Amount recalled
- 21,356 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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