The Recall Desk
LowFDA (Drugs)·D-0035-2016·Announced 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.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Ohm Laboratories, Inc. is recalling TopCare Loratadine Orally Disintegrating Tablets, 10 mg, in both Children's and standard 10-count box packaging. The recall is being conducted because the products failed to meet the required potency specifications, resulting in an out-of-specification (OOS) assay result.

The affected products were distributed nationwide. The recall includes specific batch numbers with expiration dates ranging from April 2016 to November 2016. The total quantity involved is 53,688 boxes.

Consumers who have these products should stop using them and contact their pharmacist or the recalling firm for further instructions. The FDA has classified this as a Class III recall, indicating that the violation is unlikely to cause adverse health consequences.

The recalled product

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
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Antihistamine
Hazard
Affected units
53,688

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • Batch Numbers: a) 2600127
  • Exp 2/29/2016
  • 2617892
  • Exp 5/31/2016
  • 2644265
  • 9/30/2016
  • 2625092
  • Exp
  • 6/30/2016
  • 2658140
  • Exp 11/30/2016. b) 2617892
  • 2610783
  • 4/30/2016
  • 2644272
  • Exp 9/30/2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by Ohm Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →

Related recalls

Same manufacturer · Ohm Laboratories, Inc.

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Same hazard · potency failure

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