Recalls / Class III
Class IIID-0023-2016
Product
CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
- Affected lot / code info
- Batch Numbers: a) 2644273, 2644265, Exp 9/30/2016; 2617891, 2617892, 2617893, Exp 5/31/2016; 2625093, 6/30/2016; 2544488, 7/31/2016; 2600125, 2600126, 2600127, Exp 2/29/2016; 2610783, Exp 4/30/2016 b) 2600128, Exp 2/29/2016; 2544487, Exp 7/31/2016; 2617893, Exp 5/31/2016; 2644265, Exp 9/30/2016; 2644272, Exp 9/30/2016; 2658138, Exp 11/30/2016
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
- 291,312 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-0023-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.