Drug recall D-1144-2023

Class III Terminated reported Sep 13, 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

Lots and codes

Lot #: 90000228

Recall details

Recalling firm
Caplin Steriles Limited, Gummidipoondi, N/A
Quantity
19, 820 vials
Distribution
Nationwide in Tennessee
Type
Voluntary: Firm initiated
Recall initiated
August 14, 2023
Terminated
September 9, 2025

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