FDA-Drug2023-09-13Class III
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
Caplin Steriles Limited
Hazard
Failed Impurities/Degradation Specifications
Sold states
Nationwide in Tennessee
Affected count
19, 820 vials
Manufactured in
895 & 897 Survey No, N/A, Gummidipoondi, N/A, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1144-2023Don't want to check this manually?
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