Caplin Steriles Limited recalls Milrinone Lactate Injection (20mg/20mL) due to failed impurities and degradation specifications. This medication is for prescription use only and may pose risks if not properly handled.
Failed Impurities/Degradation Specifications
Caplin Steriles Limited has recalled a specific dose of Milrinone Lactate Injection because it failed impurities and degradation tests. This medication is for prescription use only and could pose risks if not handled correctly.
The medication failed impurities and degradation specifications, which means it may contain harmful substances or break down in a way that could affect safety. This is a serious issue for prescription medications that require precise chemical stability.
Prescription patients using the recalled Milrinone Lactate Injection (20mg/20mL) in 10 x 20 mL vials per carton with NDC 72485-502-01. Patients who have this medication should contact their healthcare provider.
Check for the product name 'Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL)', packaged in 10 x 20 mL vials per carton, with NDC 72485-502-01 (single vial). This medication is distributed by Armas Pharmaceuticals, Inc. and manufactured by Caplin Steriles Limited in India.
Patients should contact their healthcare provider to discuss the recalled medication and alternative options.
The recall indicates the medication failed impurities and degradation specifications, so it is not safe to use as intended.
The NDC number for this product is 72485-502-01.
Check for the product name 'Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL)', packaged in 10 x 20 mL vials per carton, with NDC 72485-502-01.
We’ve drafted a message you can send Caplin Steriles to request your refund or repair — edit it as you like.
Subject: Recall D-1144-2023 — Caplin Steriles Caplin Steriles Hello, I own a Caplin Steriles that is covered by recall D-1144-2023 from Caplin Steriles. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
