Reported Sep 13, 2023 · Terminated
Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single…
Caplin Steriles Limited
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Caplin Steriles Limited · 895 & 897 Survey No · Gummidipoondi, N/A · N/A
Is this the product you have?
Milrinone Lactate InjectionUSP 20mg/20 mL (1mg/mL)packaged in 10 x 20 mL vials per cartonNDC 72485-502-01 (single vial)Rx only
- Distributed byArmas Pharmaceuticals, Inc. Freehold
- NJ 07728(USA) Manufactured byCaplin Steriles Limited, India, NDC 72485-502-10
- Lot codes and dates
- Lot #: 90000228
- Amount recalled
- 19, 820 vials
Where it was sold
- Nationwide
- TN
Why it was recalled
Failed Impurities/Degradation Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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