The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0029-2016·Announced 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.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a quality control issue (superpotency) without reported injuries or illnesses.

Plain-English summary

Ohm Laboratories, Inc. is recalling HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box. The recall involves 25,488 boxes distributed nationwide. The specific batch numbers and expiration dates are 2544486 (Exp 7/31/2016), 2600127 (Exp 2/29/2016), 2617891 (Exp 5/31/2016), and 2644265 (Exp 9/30/2016).

The recall was initiated because the product produced an out-of-specification (OOS) result for Assay, indicating that the drug was superpotent. This means the tablets may contain more active ingredient than the labeled amount.

Consumers who have purchased these specific batches should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

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
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Antihistamine
Hazard
Affected units
25,488

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 (8)

  • Batch Numbers: 2544486
  • Exp 7/31/2016
  • 2600127
  • Exp 2/29/2016
  • 2617891
  • Exp 5/31/2016
  • 2644265
  • 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.

See all →

Same hazard · superpotency

See all →

Similar recalls