Home / Recalls / Ohm Laboratories, Inc. / D-0039-2016

D-0039-2016 Class III Terminated

Recalled by Ohm Laboratories, Inc. — North Brunswick, NJ

FDA drug recall D-0039-2016 was initiated by Ohm Laboratories, Inc. on July 28, 2015 and is designated Class III. Reason for recall: Superpotent Drug: Out Of Specification (OOS) result for Assay. The recall status is terminated (terminated October 28, 2016). Affected quantity: 5,040 boxes.

Recall Details

Product Type: Drugs
Report Date: October 21, 2015
Initiation Date: July 28, 2015
Termination Date: October 28, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,040 boxes

Product Description

Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8

Reason for Recall

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

Distribution Pattern

Nationwide.

Code Information

Batch Number: 2610783, Exp 4/30/2016

Other recalls by Ohm Laboratories, Inc.

D-0026-2016 Class III — Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets p (July 28, 2015)
D-0036-2016 Class III — Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per (July 28, 2015)
D-0021-2016 Class III — Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, (July 28, 2015)
D-0024-2016 Class III — Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally (July 28, 2015)
D-0022-2016 Class III — CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disint (July 28, 2015)
D-0032-2016 Class III — Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Dist (July 28, 2015)
D-0027-2016 Class III — Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, pac (July 28, 2015)
D-0035-2016 Class III — TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) C (July 28, 2015)
D-0025-2016 Class III — Equaline Original Prescription Strength, loratadine orally disintegrating tablet (July 28, 2015)
D-0037-2016 Class III — Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10- (July 28, 2015)