Caplin Steriles Limited recalls Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single…

Recall date

August 14, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1144-2023

FDA classification

Class III

Brand / firm

Caplin Steriles Limited

Sold / distributed

Nationwide in Tennessee

Why it was recalled

Failed Impurities/Degradation Specifications

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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