Recall: D-1144-2023

Class III - Minor Violations

Class IIIClassification

2023-08-14Initiated

TerminatedStatus

Caplin Steriles LimitedFirm

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

Failed Impurities/Degradation Specifications

Distribution

Nationwide in Tennessee

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.