CLASS III Drug recall · Reported 13 Sep 2023 · FDA Enforcement Report
Milrinone Lactate Injection, USP 20mg/ (1mg/mL) recalled
Caplin Steriles is recalling Milrinone Lactate Injection, USP 20mg/ (1mg/mL), distributed nationwide in the US. The recall was initiated on 14 Aug 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1144-2023
- FDA event ID
- 92900
- Recalling firm
- Caplin Steriles, Gummidipoondi, N/A
- Brand
- Milrinone Lactate
- Manufacturer
- Armas Pharmaceuticals Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 14 Aug 2023
- FDA classified
- 6 Sep 2023
- Reported
- 13 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Aug 2023 | Recall initiated by company | |
| 6 Sep 2023 | Classified by FDA | +23 days |
| 13 Sep 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in Tennessee
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot #: 90000228
Where was it sold?
Nationwide in Tennessee
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Milrinone Lactate recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* recalled by Pfizer | Pfizer | Sterility | PR |
| Drug | CLASS II | Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* recalled by Pfizer | Pfizer | Sterility | PR |
| Drug | CLASS II | Milrinone Lactate in 5% Dextrose Injection recalled by Baxter HealthcareMilrinone Lactate In Dextrose | Baxter Healthcare | Sterility | IL |