The Recall Desk
LowFDA (Drugs)·D-0020-2016·Announced 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.

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 Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg. The recall involves 90,410 units of the medication, which are distributed nationwide. The product is available in 30-count and 60-count boxes, identified by specific item numbers and UPC codes.

The recall was initiated because the product failed an out-of-specification (OOS) result for Assay. This failure led to the product being classified as a superpotent drug, meaning the tablets may contain more active ingredient than intended. The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.

Consumers who have purchased these specific tablets should stop using them and return them to the pharmacy where they were purchased for a refund or replacement. The affected batch numbers and expiration dates are listed in the official recall notice.

The recalled product

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.
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Oral Solid Dosage
Hazard
Affected units
90,410

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) 2658137
  • Exp 11/30/2016
  • 2644272
  • Exp 9/30/2016
  • 2625093
  • 2625092 Exp 6/30/2016
  • 2617892
  • Exp 5/31/2016
  • 2610783
  • Exp 4/30/2016
  • 2600126
  • 2600128
  • Exp 2/29/2016 b) 2625093
  • Exp 6/30/2016
  • Exp 2/29/2016

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 · superpotent drug

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