The Recall Desk

FDA (Drugs) recall action 71973

Ohm Laboratories, Inc. recalled 21 products on 2015-10-21

The FDA (Drugs) publishes a recall like this one as 21 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 21 pages.

Products
21
Announced
2015-10-21
Critical
0
Units
1,059,544

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–21 of 21

  • ModerateFDA (Drugs)··2015-10-21

    QC Quality Choice Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling QC Quality Choice Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result.

    Product
    QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0
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    0 states
  • LowFDA (Drugs)··2015-10-21

    CVS Loratadine Tablets Recalled for Out-of-Specification Assay Results

    CVS Pharmacy loratadine tablets are being recalled because they failed potency testing. Consumers should stop using the product and return it to the pharmacy.

    Product
    CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc. On
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    0 states
  • ModerateFDA (Drugs)··2015-10-21

    Ohm Laboratories Recalls Loratadine Tablets Due to Potency Issues

    Ohm Laboratories is recalling specific batches of loratadine orally disintegrating tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0073-1, UPC 0 5256913369 9
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    0 states
  • ModerateFDA (Drugs)··2015-10-21

    Ohm Laboratories Recalls Loratadine Tablets Due to Out-of-Specification Assay

    Ohm Laboratories is recalling specific lots of loratadine tablets because they failed potency testing. Consumers should stop using the affected medication.

    Product
    Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by: Drug Mart-Food Fair, Medina, OH 44256, UPC 0 93351 12101 2.
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    0 states
  • ModerateFDA (Drugs)··2015-10-21

    Ohm Recalls HEB Loratadine Tablets Due to Out-of-Specification Assay

    Ohm Laboratories is recalling HEB Loratadine Orally Disintegrating Tablets because an out-of-specification assay result indicated the drug was superpotent.

    Product
    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
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    0 states
  • LowFDA (Drugs)··2015-10-21

    Major Loratadine Tablets Recalled for Out-of-Specification Assay Results

    Ohm Laboratories is recalling Major loratadine orally disintegrating tablets due to out-of-specification assay results. The recall covers 29,360 boxes distributed nationwide.

    Product
    Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9
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    0 states
  • ModerateFDA (Drugs)··2015-10-21

    Ohm Recalls Loratadine Tablets Due to Out-of-Specification Assay Results

    Ohm Laboratories is recalling specific batches of Leader Loratadine Orally Disintegrating Tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7
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    0 states
  • LowFDA (Drugs)··2015-10-21

    Sunmark Loratadine Tablets Recalled for Out-of-Specification Assay Results

    Ohm Laboratories is recalling Sunmark loratadine tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104
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    0 states
  • ModerateFDA (Drugs)··2015-10-21

    Meijer Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling Meijer Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result.

    Product
    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
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    0 states
  • LowFDA (Drugs)··2015-10-21

    Loratadine Tablets Recalled for Out-of-Specification Assay Results

    Ohm Laboratories is recalling CareOne Loratadine tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    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
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    0 states
  • LowFDA (Drugs)··2015-10-21

    Ohm Laboratories Recalls Loratadine Tablets Due to Assay Failure

    Ohm Laboratories is recalling specific batches of loratadine tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, MO 64111; UPC 0 7003861209 4
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    0 states
  • ModerateFDA (Drugs)··2015-10-21

    Ohm Laboratories Recalls Loratadine Tablets for Out-of-Specification Assay

    Ohm Laboratories is recalling Premier Value Loratadine Orally Disintegrating Tablets because an assay test result was out of specification.

    Product
    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
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    0 states
  • LowFDA (Drugs)··2015-10-21

    Safeway Care Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling Safeway Care Loratadine Orally Disintegrating Tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566
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    0 states
  • LowFDA (Drugs)··2015-10-21

    TopCare Loratadine Tablets Recalled for Out-of-Specification Assay Results

    Ohm Laboratories is recalling TopCare Loratadine tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Vill
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    0 states
  • LowFDA (Drugs)··2015-10-21

    Ohm Laboratories Recalls Loratadine Tablets Due to Potency Issues

    Ohm Laboratories is recalling Wal-itin Loratadine Orally Disintegrating Tablets because they failed potency testing. The FDA classified this as a Class III recall.

    Product
    Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot
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    0 states
  • LowFDA (Drugs)··2015-10-21

    Fred's Loratadine Tablets Recalled for Out-of-Specification Assay Results

    Ohm Laboratories is recalling Fred's Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result. The FDA classifies this as a Class III recall.

    Product
    Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.
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    0 states
  • ModerateFDA (Drugs)··2015-10-21

    Good Neighbor Pharmacy Loratadine Tablets Recalled for Potency Issues

    Ohm Laboratories is recalling Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets because they failed potency testing.

    Product
    Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-0161-52, ABC # 042-226, UPC 0 8770140650 8; b) For adults 10-count tablets, NDC 46122-0140-52, ABC# 059-535, UPC 0877014065546, Distributed by:
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    0 states
  • ModerateFDA (Drugs)··2015-10-21

    Ohm Recalls Up&Up Loratadine Tablets for Out-of-Specification Assay

    Ohm Laboratories is recalling Up&Up loratadine tablets because they failed an assay test, potentially making them superpotent.

    Product
    Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis, MN 55403; NDC 11673-527-31, UPC 3 5166052731 5
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    0 states
  • LowFDA (Drugs)··2015-10-21

    Rite Aid Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling Rite Aid Pharmacy loratadine orally disintegrating tablets because they failed an assay test, resulting in a superpotent drug classification.

    Product
    Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52712 5; b) 60-count tablets per box, Item 353672, UPC 0 11822 53672 1. Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011.
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    0 states
  • ModerateFDA (Drugs)··2015-10-21

    Ohm Laboratories Recalls Equaline Loratadine Tablets for Assay Failure

    Ohm Laboratories is recalling Equaline loratadine tablets because they failed potency testing. Consumers should stop using the product and return it to the pharmacy.

    Product
    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
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    0 states