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FDAJuly 28, 2015drug

CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sale...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Superpotent Drug: Out Of Specification (OOS) result for Assay.

What to do

FDA enforcement status: Terminated

Brands named

ohm laboratoriesohm

UPCs

341520313462341520314551

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sale... — Recall Details · AllClear