Recalls / Class III
Class IIID-0022-2016
Product
CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086
- Affected lot / code info
- Batch Numbers: (a) 2617891, Exp 5/31/2016; 2600127, Exp 2/29/2016; 2544487, Exp 7/31/2015; 2610783, Exp 4/30/2016 (b) 2600127, Exp 2/29/2016; 2544487, Exp 7/31/2015; 2617891, Exp 5/31/2016; 2644272, 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
- 21,356 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-0022-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.