Ohm Laboratories Recalls Loratadine Tablets Due to Out-of-Specification Assay
Ohm Laboratories is recalling specific lots of loratadine tablets because they failed potency testing. Consumers should stop using the affected medication.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 indicates is typically a score of 1 or 2. A score of 2 is assigned due to the potential for therapeutic failure associated with the out-of-specification assay result.
Plain-English summary
Ohm Laboratories, Inc. is recalling 4,176 units of Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box. The product is distributed by Drug Mart-Food Fair in Medina, OH, and carries the UPC 0 93351 12101 2.
The recall was initiated because the product produced an Out Of Specification (OOS) result for Assay, indicating that the medication did not meet the required potency standards. The affected batch number is 2617892, with an expiration date of 5/31/2016. The recall is classified as Class III by the FDA.
The product was distributed nationwide. Consumers who have this specific product should stop using it and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by: Drug Mart-Food Fair, Medina, OH 44256, UPC 0 93351 12101 2.
- Manufacturer
- Ohm Laboratories, Inc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 4,176
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 (2)
- Batch Numbers: 2617892
- Exp 5/31/2016
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
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