Ohm Laboratories Recalls Loratadine Tablets Due to Assay Failure
Ohm Laboratories is recalling specific batches of loratadine tablets because they failed potency testing. Consumers should stop using the affected products.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates that use of the product is not likely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Ohm Laboratories, Inc. is recalling Health Best Choice Care Loratadine Orally Disintegrating Tablets, USP, 10 mg. The recall involves 18,576 boxes of the 10-count tablets distributed nationwide by Valu Merchandisers, Co. The affected products are identified by specific batch numbers and expiration dates listed in the recall notice.
The recall was initiated because the product failed to meet specifications for assay, a test that measures the amount of active ingredient in the drug. This is classified as a superpotent drug issue, meaning the tablets may contain more active ingredient than intended. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who have purchased these specific batches of loratadine tablets should stop using them and contact their healthcare provider or pharmacist for guidance. The affected products were sold nationwide.
The recalled product
- Product
- Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, MO 64111; UPC 0 7003861209 4
- Manufacturer
- Ohm Laboratories, Inc.
- Category
- Drug — Oral Solid Dosage
- Hazard
- Affected units
- 18,576
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 (6)
- Batch Numbers: 2625092
- Exp 6/30/2016
- 2644265
- Exp 9/30/2016
- 2600126
- Exp 2/29/2016
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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