Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported September 13, 2023
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
Failed Impurities/Degradation Specifications
Caplin Steriles Limited recalled Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per ca… - a low-severity action.
Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per ca… was recalled by Caplin Steriles Limited in September 13, 2023. Reason: Failed Impurities/Degradation Specifications. Check the official notice for the remedy. Verify recall #D-1144-2023 with the FDA Drug before acting.
The recall
Caplin Steriles Limited issued this low-severity FDA Drug recall-Failed Impurities/Degradation Specifications.
- Low
- severity level
- Class III
- classification
- September 13, 2023
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1144-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1144-2023) was formally reported on September 13, 2023, with the manufacturer initiating the action on August 14, 2023. It is classified under Low severity (Class III), with a current status of Terminated. Caplin Steriles Limited is listed as the recalling firm, operating out of Gummidipoondi, N/A. Federal records list the affected scope as 19, 820 vials.
The documented reason for this recall is: Failed Impurities/Degradation Specifications Distribution data in the federal record shows the product reached: Nationwide in Tennessee. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
19, 820 vials
Related Recalls
6
5 from same agency
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-1144-2023 |
| Date reported | September 13, 2023 |
| Date initiated | August 14, 2023 |
| Recalling firm | Caplin Steriles Limited |
| Firm location | Gummidipoondi, N/A |
| Affected scope | 19, 820 vials |
| Distribution | Nationwide in Tennessee |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1144-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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.
Where was the recalled product distributed? ▼
Distribution: Nationwide in Tennessee.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1144-2023) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported September 13, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.