CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086
Reported: October 21, 2015 Initiated: July 28, 2015 #D-0022-2016
Product Description
CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086
Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Details
- Recalling Firm
- Ohm Laboratories, Inc.
- Units Affected
- 21,356 boxes
- Distribution
- Nationwide.
- Location
- North Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086. Recalled by Ohm Laboratories, Inc.. Units affected: 21,356 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-0022-2016.
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