Class II · Moderate risk Terminated
Desloratadine Tablets USP 5mg a) 100 count
Reason CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
CareOne Original Prescription Strength
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Superpotent Drug: Out Of Specification (OOS) result for Assay.
What was recalled
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
- Recalling firm
- Ohm Laboratories, Inc.
- NDC code
- 41520-525-69
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0022-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Loratadine recalls
See all
Class II · Moderate risk Ongoing
Claritin Allergy Liq Chldrns Grape 2 Floz Sku 900834 Claritin…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class III · Low risk Terminated
AllerClear D-24 hr
Reason Failed Moisture Limits
Class III · Low risk Terminated
Loratadine-D Extended-Release Tablets
Reason Failed Moisture Limits
Class II · Moderate risk Terminated
Children's Loratadine Oral Solution USP
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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