PlainRecalls
FDA Drug Low Class III Terminated

HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3

Reported: October 21, 2015 Initiated: July 28, 2015 #D-0029-2016

Product Description

HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3

Reason for Recall

Superpotent Drug: Out Of Specification (OOS) result for Assay.

Details

Recalling Firm
Ohm Laboratories, Inc.
Units Affected
25,488 boxes
Distribution
Nationwide.
Location
North Brunswick, NJ

Frequently Asked Questions

What product was recalled?
HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3. Recalled by Ohm Laboratories, Inc.. Units affected: 25,488 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-0029-2016.