Recalls / Class III
Class IIID-0025-2016
Product
Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41163-528-69, UPC 0 4116347138 2; and b) 30-count tablets per box, NDC 41163-528-31, UPC 0 4116346654 8; Distributed by: Supervalu Inc. Eden Prarie, MN 55344 USA
- Affected lot / code info
- Batch Numbers: a) 2617892, Exp 5/31/2016; 2625092, Exp 6/30/2016; 2544486, 2544488, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2644265, Exp 9/30/2016 b) 2544486, 2544488, Exp 7/31/2016; 2600127, Exp 2/29/2016; 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
- 43,344 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-0025-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.