FDA Drug recall D-0031-2016
Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise…
- FDA Drug
- Class III
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class III recall of Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise… 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-0031-2016 |
| 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
Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9
Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Identifiers
| upc | 309045806159 |
|---|---|
| code_info | Batch Numbers: 2644265, Exp 9/30/2016; 2658140, Exp 11/30/2016; 2625092, 2617891, Exp 5/31/2016; 2600127, Exp 2/29/2016; 2544488, 2544486, Exp 7/31/2016 |
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-0031-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.