FDAClass IINovember 13, 2019

S-amitriptyline 10mg/ml MDV INJ Soln recall: Sterility Concern

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

Why was S-amitriptyline 10mg/ml MDV INJ Soln recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: S06272019DT@08, BUD: 9/27/2019

Product
S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX
Recalling firm
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Quantity
2 x 30 mL vials
Distribution
Nationwide in the USA
Recall date
November 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls