FDA Drug recall D-0038-2016
Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC…
- FDA Drug
- Class III
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class III recall of Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC… by Ohm Laboratories, citing superpotent Drug: Out Of Specification (OOS) result for Assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0038-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-07-28 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Ohm Laboratories |
| Distribution | US |
Product
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
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Identifiers
| upc | 311917170213 |
|---|---|
| code_info | Batch Numbers: a) 2625093, Exp 6/30/2016; 2617893, Exp 5/31/2016; 2658137, 2658140, Exp 11/30/2016; 2644265, Exp 9/30…Batch Numbers: a) 2625093, Exp 6/30/2016; 2617893, Exp 5/31/2016; 2658137, 2658140, Exp 11/30/2016; 2644265, Exp 9/30/2016 b) 2544486, 2544487, 2544488, Exp 7/31/2016; 2600125, 2600126, 2600127, Exp 2/29/2016; 2644272, 2644273, 2644265, Exp 9/30/2016; 2625092, 2625093, Exp 6/30/2016; 2658137, 2658138, 2658140 Exp 11/30/2016; 2610783, Exp 4/30/2016; 2617891, Exp 5/31/2016. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0038-2016%22
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