Reported Oct 21, 2015 · Terminated
Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 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?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and |
| 2 | 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 |
| 3 | Distributed by McKesson, One Post Street, San Francisco, CA 94104 |
- Lot codes and dates
- Batch Numbers
(a) 2544488Exp 7/31/201626917891Exp 5/31/2016. (b) 2544488Exp 7/31/20162617893Exp 5/31/20162644273Exp 9/30/2016
- Batch Numbers
- Amount recalled
- N/A
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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