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
Reported: September 13, 2023 Initiated: August 14, 2023 #D-1144-2023
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
Details
- Recalling Firm
- Caplin Steriles Limited
- Units Affected
- 19, 820 vials
- Distribution
- Nationwide in Tennessee
- Location
- Gummidipoondi, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Caplin Steriles Limited. Units affected: 19, 820 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 13, 2023. Severity: Low. Recall number: D-1144-2023.
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