Caplin Steriles Limited: Drug Recall
Recall #D-1144-2023 · 08/14/2023
Class III: Low Risk
Recall Details
- Recall Number
- D-1144-2023
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Caplin Steriles Limited
- Status
- Terminated
- Date Initiated
- 08/14/2023
- Location
- Gummidipoondi, N/A, India
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19, 820 vials
Reason for Recall
Failed Impurities/Degradation Specifications
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
Distribution Pattern
Nationwide in Tennessee
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.