Recalls / Class III
Class IIID-0038-2016
Product
Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015
- Affected lot / code info
- Batch Numbers: a) 2625093, Exp 6/30/2016; 2617893, Exp 5/31/2016; 2658137, 2658140, Exp 11/30/2016; 2644265, Exp 9/30/2016 b) 2544486, 2544487, 2544488, Exp 7/31/2016; 2600125, 2600126, 2600127, Exp 2/29/2016; 2644272, 2644273, 2644265, Exp 9/30/2016; 2625092, 2625093, Exp 6/30/2016; 2658137, 2658138, 2658140 Exp 11/30/2016; 2610783, Exp 4/30/2016; 2617891, Exp 5/31/2016.
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
- 329,748 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-0038-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.