Ohm Laboratories Recalls Loratadine Tablets Due to Potency Issues
Ohm Laboratories is recalling specific batches of 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 the rubric defines as unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2. The specific hazard is a potency deviation without reported injuries.
Plain-English summary
Ohm Laboratories, Inc. is recalling 35,712 boxes of Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg. The recall was initiated because the product produced an out-of-specification (OOS) result for assay, indicating a superpotent drug issue. The affected product is distributed by McKesson and is available nationwide.
The recall involves specific batch numbers: 2544488 (Exp 7/31/2016), 2617892 (Exp 5/31/2016), and 2625092 (Exp 6/30/2016). The product is identified by NDC 62011-0073-1 and UPC 0 5256913369 9.
Consumers who have these specific batches of loratadine tablets should stop using them and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0073-1, UPC 0 5256913369 9
- Manufacturer
- Ohm Laboratories, Inc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 35,712
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 (7)
- Batch Numbers: 2544488
- Exp
- 7/31/2016
- 2617892
- 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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