FDA-Drug2015-10-21Class III

Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2

Ohm Laboratories, Inc.
Hazard

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

Sold states
Nationwide.
Affected count
11,232 boxes
Manufactured in
1385 Livingston Ave, N/A, North Brunswick, NJ, United States
Products
Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0033-2016

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