Recalls / Class III
Class IIID-0032-2016
Product
Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5
- Brand name
- Allergy Relief
- Generic name
- Loratadine
- Active ingredient
- Loratadine
- Route
- Oral
- NDC
- 51660-527
- FDA application
- ANDA077153
- Affected lot / code info
- Batch Numbers: 2544486, Exp 7/31/2016; 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.
- Manufacturer
- Ohm Laboratories Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1385 Livingston Ave, N/A, North Brunswick, New Jersey 08902-1829
Distribution
- Quantity
- 311 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-0032-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.