The Recall Desk
ModerateFDA (Drugs)·D-0025-2016·Announced 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.

What this means for you

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 the rubric associates with low-risk issues or voluntary precautionary recalls where adverse health consequences are unlikely.

Plain-English summary

Ohm Laboratories, Inc. is recalling Equaline Original Prescription Strength loratadine orally disintegrating tablets, 10 mg. The recall involves 10-count and 30-count boxes distributed nationwide by Supervalu Inc. The specific batch numbers and expiration dates are listed in the official recall notice.

The recall was initiated because the product failed to meet the required potency specifications, resulting in an out-of-specification (OOS) result for the assay. This means the amount of active ingredient in the tablets may not be consistent with the labeled strength.

Consumers who have this product should stop using it and return it to the pharmacy where it was purchased. The FDA has classified this recall as Class III, indicating that the product is unlikely to cause adverse health consequences.

The recalled product

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
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Antihistamine
Hazard
Affected units
43,344

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 (12)

  • Batch Numbers: a) 2617892
  • Exp 5/31/2016
  • 2625092
  • Exp 6/30/2016
  • 2544486
  • 2544488
  • Exp 7/31/2016
  • 2600127
  • Exp 2/29/2016
  • 2644265
  • Exp 9/30/2016 b) 2544486
  • 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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