Ohm Recalls Loratadine Tablets Due to Out-of-Specification Assay Results
Ohm Laboratories is recalling specific batches of Leader Loratadine Orally Disintegrating Tablets because they failed potency testing. Consumers should stop using the affected products.
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 indicates the product is not likely to cause adverse health consequences. The hazard is a potency deviation without reported injuries or illnesses.
Plain-English summary
Ohm Laboratories, Inc. is recalling 9,624 boxes of Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg. The recall involves specific batches with expiration dates of May 31, 2016, and June 30, 2016. The product was distributed nationwide by Cardinal Health.
The recall was initiated because the product produced an out-of-specification (OOS) result for Assay, indicating that the drug potency did not meet required standards. This is classified as a superpotent drug issue.
Consumers who have these specific products should stop using them and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7
- Manufacturer
- Ohm Laboratories, Inc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 9,624
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 (4)
- Batch Numbers: 2617891
- Exp 5/31/2016
- 2625092
- Exp 6/30/2016
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.
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