FDA recall D-1144-2023

Product

Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide in Tennessee

Key facts

Status

Terminated

Initiation date

2023-08-14

Report date

2023-09-13

Termination date

2025-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gummidipoondi, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1144-2023