TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.
Reported: October 21, 2015 Initiated: July 28, 2015 #D-0035-2016
Product Description
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.
Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Details
- Recalling Firm
- Ohm Laboratories, Inc.
- Units Affected
- 53,688 boxes
- Distribution
- Nationwide.
- Location
- North Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.. Recalled by Ohm Laboratories, Inc.. Units affected: 53,688 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-0035-2016.
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