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
Reported: October 21, 2015 Initiated: July 28, 2015 #D-0030-2016
Product Description
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
Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Details
- Recalling Firm
- Ohm Laboratories, Inc.
- Units Affected
- 9,624 boxes
- Distribution
- Nationwide.
- Location
- North Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ohm Laboratories, Inc.. Units affected: 9,624 boxes.
Why was this product recalled? ▼
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 21, 2015. Severity: Low. Recall number: D-0030-2016.
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