Drugplain

LORATADINE 5 mg/1

LORATADINE · TABLET, CHEWABLE · Rite Aid

10 Recalls on Record
Plain English

LORATADINE is a tablet, chewable containing loratadine at 5 mg/1, taken oral. Manufactured by Rite Aid.

Key Facts

Brand Name
LORATADINE
Generic Name
LORATADINE
NDC Code (Product)
11822-7240
Manufacturer
Rite Aid
Strength
5 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
ANDA210088
Marketing Start
04/01/2018

Recall History

10 Recalls on Record
Class III07/28/2015

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

TerminatedVoluntary: Firm initiated
Class III07/28/2015

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

TerminatedVoluntary: Firm initiated
Class III07/28/2015

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

TerminatedVoluntary: Firm initiated
Class II02/07/2014

Ohm Laboratories, Inc.

Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup; LORATADINE Tablet, 10 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W002650, EXP: 6/5/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 05445800022, Pedigree: AD21858_4, EXP: 5/1/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003217, EXP: 6/14/2014.

TerminatedVoluntary: Firm initiated
Class III07/28/2015

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class III07/28/2015

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

TerminatedVoluntary: Firm initiated
Class III07/28/2015

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

TerminatedVoluntary: Firm initiated
Class III07/28/2015

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective3,764 reports
fatigue3,264 reports
nausea2,745 reports
dyspnoea2,464 reports
headache2,449 reports
diarrhoea2,396 reports
off label use2,268 reports
dizziness2,124 reports
pain2,004 reports
rash1,639 reports

Frequently Asked Questions

What is LORATADINE used for?

LORATADINE contains LORATADINE. It is a tablet, chewable taken oral. Consult your doctor for specific uses.

Is LORATADINE a controlled substance?

LORATADINE is not classified as a controlled substance by the DEA.

What is the generic name for LORATADINE?

The generic name for LORATADINE is LORATADINE. There are 12 other brand versions of LORATADINE.

What is the NDC code for LORATADINE 5 mg/1?

The NDC (National Drug Code) for LORATADINE 5 mg/1 is 11822-7240, listed by Rite Aid.