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Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, ND...

FDA Recall #D-1144-2023 — Class III — August 14, 2023

Recall #D-1144-2023 Date: August 14, 2023 Classification: Class III Status: Terminated

Product Description

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

Recalling Firm

Caplin Steriles Limited — Gummidipoondi, N/A

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

19, 820 vials

Distribution

Nationwide in Tennessee

Code Information

Lot #: 90000228

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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