FDA-Drug2015-10-21Class III

HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3

Ohm Laboratories, Inc.
Hazard

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

Sold states
Nationwide.
Affected count
25,488 boxes
Manufactured in
1385 Livingston Ave, N/A, North Brunswick, NJ, United States
Products
HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0029-2016

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