D-0198-2020 Class II Terminated
FDA drug recall D-0198-2020 was initiated by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy on August 12, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated April 13, 2023). Affected quantity: 2 x 30 mL vials.
Recall Details
- Product Type
- Drugs
- Report Date
- November 13, 2019
- Initiation Date
- August 12, 2019
- Termination Date
- April 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 x 30 mL vials
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
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: S06272019DT@08, BUD: 9/27/2019