The Recall Desk
ModerateFDA (Drugs)·D-0027-2016·Announced 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.

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 is defined as unlikely to cause adverse health consequences. The hazard is a potency deviation without reported injuries.

Plain-English summary

Ohm Laboratories, Inc. is recalling Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg. The recall involves specific batches of the medication packaged for both children and adults, distributed nationwide by AmerisourceBergen.

The recall was initiated because the product produced an out-of-specification (OOS) result for Assay, which indicates the medication is superpotent. This means the tablets contain a higher amount of the active ingredient than intended.

Consumers with the affected products should stop using them and return them to the pharmacy where they were purchased or contact Ohm Laboratories for instructions on how to dispose of the medication.

The recalled product

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:
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Antihistamine
Hazard

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 (5)

  • Batch Numbers: a) 2625092
  • Exp 6/30/2016
  • 2610783
  • Exp 4/30/2016 b) 2625093
  • Exp 4/30/2016

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 · superpotent drug

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