Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Far...

FDA Recall #D-0777-2022 — Class II — April 5, 2022

Recall #D-0777-2022 Date: April 5, 2022 Classification: Class II Status: Terminated

Product Description

Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

Reason for Recall

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Recalling Firm

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding — Richardson, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

189 vials

Distribution

Nationwide within United States

Code Information

Lot #: 32961 BUD: 5/12/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

Browse All Drug Recalls Drug Recall Stats Drug Safety Home
Back to All Drug Recalls