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
Reported: October 21, 2015 Initiated: July 28, 2015 #D-0038-2016
Product Description
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
Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Details
- Recalling Firm
- Ohm Laboratories, Inc.
- Units Affected
- 329,748 boxes
- Distribution
- Nationwide.
- Location
- North Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ohm Laboratories, Inc.. Units affected: 329,748 boxes.
Why was this product recalled? ▼
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 21, 2015. Severity: Low. Recall number: D-0038-2016.
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