PlainRecalls
FDA Drug Moderate Class II Terminated

S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX

Reported: November 13, 2019 Initiated: August 12, 2019 #D-0198-2020

Product Description

S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
2 x 30 mL vials
Distribution
Nationwide in the USA
Location
Mesa, AZ

Frequently Asked Questions

What product was recalled?
S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX. Recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy. Units affected: 2 x 30 mL vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on November 13, 2019. Severity: Moderate. Recall number: D-0198-2020.