FDA-Drug2015-10-21Class III

Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41163-528-69, UPC 0 4116347138 2; and b) 30-count tablets per box, NDC 41163-528-31, UPC 0 4116346654 8; Distributed by: Supervalu Inc. Eden Prarie, MN 55344 USA

Ohm Laboratories, Inc.
Hazard

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

Sold states
Nationwide.
Affected count
43,344 boxes
Manufactured in
1385 Livingston Ave, N/A, North Brunswick, NJ, United States
Products
Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41163-528-69, UPC 0 4116347138 2; and b) 30-count tablets per box, NDC 41163-528-31, UPC 0 4116346654 8; Distributed by: Supervalu Inc. Eden Prarie, MN 55344 USA

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0025-2016

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