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Home Prescription medicine Caplin Steriles Limited — Milrinone Lactate…

Food & drug recall · FDAAugust 14, 2023Labelling issue

Caplin Steriles Limited — 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

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

Failed Impurities/Degradation Specifications

The Recall Registry rates this labelling issueFDA Class III: unlikely to cause harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Caplin Steriles Limited

The 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

Details

Units affected
19, 820 vials
Recall date
August 14, 2023
Brand
Caplin Steriles Limited
Model, lot or SKU numbers
Lot #: 90000228
Where it was distributed

Nationwide in Tennessee

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: Caplin Steriles Limited — 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) Manufactur

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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