This website is not monitored for medical emergencies. If a person may be experiencing a serious or life-threatening reaction, call 911 or seek immediate emergency medical assistance. Do not wait for a response from Unvari, Clinic Protocols or a website contact channel.
Prompt reporting supports product quality and patient safety
Healthcare professionals and authorized practice representatives should promptly report suspected product-quality issues involving an Unvari-branded product.
Suspected adverse events should be reported to the treating practitioner and the dispensing pharmacy identified on the prescription label or pharmacy documentation. Reports may also be submitted directly to FDA MedWatch.
Reporting a concern does not establish that the product caused an event or that a defect has been confirmed. Reports allow the appropriate parties to evaluate the available information and determine whether investigation or follow-up is necessary.
Identify the type of concern
Product-quality complaint
A concern about the condition, identity, packaging, labeling, container, appearance, shipping condition or documented specifications of a product, whether or not an injury or reaction occurred.
Suspected adverse event
An unfavorable or unexpected health occurrence associated in time with the use of a preparation, whether or not the preparation is believed to have caused the occurrence.
A single report may involve both a product-quality concern and a suspected adverse event. When that occurs, contact the dispensing pharmacy and treating practitioner promptly and report both aspects of the concern.
Examples of concerns to report
Cracked vial, damaged closure, loose cap, leakage or compromised seal.
Missing, damaged, unreadable, incorrect or inconsistent label information.
Unexpected color, particles, cloudiness, residue, foreign material or another visible difference.
Damaged package, suspected temperature excursion, missing item or delivery irregularity.
Incorrect item, count, formulation, strength, lot number or package configuration.
Unrecognized packaging, altered labeling, suspicious seller or questionable product origin.
Do not use a product that appears damaged, contaminated, mislabeled, compromised or materially different from the expected condition. Isolate it from usable inventory and contact the dispensing pharmacy for instructions.
Contact the clinical and dispensing professionals
A patient experiencing an unexpected health effect should contact the treating practitioner promptly. The practitioner or authorized reporter should also contact the licensed pharmacy identified on the dispensing label or pharmacy documentation.
The dispensing pharmacy is best positioned to identify the prescription, preparation, dispensing record and patient-specific information needed for an initial review.
Unvari.com does not collect patient data. Do not place a patient’s name, date of birth, diagnosis, medical history, prescription, laboratory information, treatment details or medical records into the public partnership form or general support email.
Details that support an efficient investigation
For a product-quality complaint that does not contain patient information, provide as much of the following information as is available:
- ✓ Product or formulation name.
- ✓ Strength, vial size and package configuration.
- ✓ Lot or batch number and expiration or beyond-use date shown on the label.
- ✓ Dispensing pharmacy identified on the label or paperwork.
- ✓ Date received and date the concern was discovered.
- ✓ Clear description of the observed issue and the quantity affected.
- ✓ Storage, handling and shipping conditions known to the reporter.
- ✓ Photographs of the product, label and packaging that do not contain patient information.
- ✓ Reporter’s name, role, organization and business contact information.
Do not discard or return it without instructions
Unless immediate disposal is necessary to protect safety, retain the affected product, vial, label, carton, shipping materials and any unused portion in a secure location.
Maintain the product under the storage conditions specified on its labeling unless the dispensing pharmacy provides different written instructions.
Do not ship or return a product until the dispensing pharmacy or authorized complaint investigator provides return, quarantine or disposal instructions.
Use the pharmacy information on the label
Patient-specific preparations are dispensed by participating licensed compounding pharmacies. The responsible dispensing pharmacy is identified on the prescription label, patient documentation, invoice or accompanying pharmacy materials.
Contact that pharmacy for questions involving the patient-specific prescription, dispensing record, preparation, administration instructions, suspected adverse event, replacement determination or return authorization.
Unvari LLC does not independently prescribe, compound or dispense patient-specific preparations and cannot replace the professional review performed by the practitioner or dispensing pharmacy.
Reports may also be submitted directly to FDA
Healthcare professionals, patients and consumers may voluntarily report suspected serious reactions, product-quality problems, therapeutic failures or product-use errors involving medicines through FDA’s MedWatch program.
FDA MedWatch reporting options
Reporting to Unvari, a practitioner or a pharmacy does not prevent a reporter from also submitting information directly to FDA.
Unvari.com remains a no-patient-data website
This page does not contain an adverse-event form because Unvari.com does not collect patient information. Patient-specific reports must be directed to the treating practitioner, dispensing pharmacy or FDA MedWatch through their designated systems.
A product-quality complaint submitted to Unvari should be limited to product, lot, packaging, shipping and professional-business information.
Patient names, dates of birth, addresses, photographs, diagnoses, medical histories, prescriptions, treatment details, laboratory results, insurance information, medical records or other patient identifiers.
Complaints may require coordinated review
Receives appropriate brand-level product-quality information and may coordinate with relevant partners.
May evaluate manufacturing, lot, testing, packaging or production-related information.
May support communication with qualified practices and applicable distribution records.
Reviews the patient-specific prescription, dispensing record and applicable adverse-event information.
Use the dedicated complaint channel
Authorized healthcare-practice representatives may use the contact information below to report an Unvari product-quality concern that does not contain patient information. For suspected adverse events, contact the treating practitioner, dispensing pharmacy and FDA MedWatch as appropriate.
68 E Serene Ave, Unit 103
Las Vegas, NV 89123
Please have the product name, lot number, expiration or beyond-use date, dispensing pharmacy name and a brief description of the concern available. If possible, include clear photographs of the product and packaging. Do not send patient names, medical records, prescriptions or other protected health information through email.
Do not send patient information through these Unvari channels. Patient-specific information should be provided directly to the treating practitioner, dispensing pharmacy or FDA using the appropriate secure reporting process.