FDA Drug recall D-0027-2016
Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-01…
- FDA Drug
- Class III
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class III recall of Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-01… 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-0027-2016 |
| 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
Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-0161-52, ABC # 042-226, UPC 0 8770140650 8; b) For adults 10-count tablets, NDC 46122-0140-52, ABC# 059-535, UPC 0877014065546, Distributed by: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087
Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Identifiers
| upc | 087701406508 |
|---|---|
| upc | 0877014065546 |
| code_info | Batch Numbers: a) 2625092, Exp 6/30/2016; 2610783, Exp 4/30/2016 b) 2625093, Exp 6/30/2016, 2610783, Exp 4/30/2016 |
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-0027-2016%22
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