LORATADINE

Generic: LORATADINE ORAL

Better Living Brands LLCManufacturer

ORALRoute

LORATADINEActive Substance

2018-06-29Original Approval

LORATADINE is FDA application ANDA208931, sponsored by AUROBINDO PHARMA LTD. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2014-02-07

Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP,

Defective Container: An unacceptable level of blister defects have been identified in Loratadine and

Class II2021-03-15

Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Class III2021-10-12

Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg)

Failed Moisture Limits

Top Reported Reactions

1

DRUG INEFFECTIVE

3,837 reports

2

FATIGUE

3,334 reports

3

NAUSEA

2,797 reports

4

DYSPNOEA

2,523 reports

5

HEADACHE

2,502 reports

6

DIARRHOEA

2,458 reports

7

OFF LABEL USE

2,322 reports

8

DIZZINESS

2,173 reports

9

PAIN

2,043 reports

10

RASH

1,671 reports