Recalls / Class III
Class IIID-0029-2016
Product
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
- Affected lot / code info
- Batch Numbers: 2544486, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2617891, Exp 5/31/2016; 2644265, Exp 9/30/2016
Why it was recalled
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Recalling firm
- Firm
- Ohm Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1385 Livingston Ave, N/A, North Brunswick, New Jersey 08902-1829
Distribution
- Quantity
- 25,488 boxes
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2015-07-28
- FDA classified
- 2015-10-15
- Posted by FDA
- 2015-10-21
- Terminated
- 2016-10-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0029-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.