FDA-Drug2015-10-21Class III
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 Sales Company, 4201 Walden Avenue, Lancaster, NY 14086
Ohm Laboratories, Inc.
Hazard
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Sold states
Nationwide.
Affected count
21,356 boxes
Manufactured in
1385 Livingston Ave, N/A, North Brunswick, NJ, United States
Products
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 Sales Company, 4201 Walden Avenue, Lancaster, NY 14086
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0022-2016Don't want to check this manually?
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