Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported August 8, 2012
Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fiber…
Eagle Pharmaceuticals Inc. recalled Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Sing… - a critical-severity action.
Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Sing… was recalled by Eagle Pharmaceuticals Inc. in August 8, 2012. Reason: A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial f…. Check the official notice for the remedy. Verify recall #D-1429-2012 with the FDA Drug before acting.
The recall
Eagle Pharmaceuticals Inc. issued this critical-severity FDA Drug recall-A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial f….
- Critical
- severity level
- Class I
- classification
- August 8, 2012
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1429-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1429-2012) was formally reported on August 8, 2012, with the manufacturer initiating the action on December 2, 2011. It is classified under Critical severity (Class I), with a current status of Terminated. Eagle Pharmaceuticals Inc. is listed as the recalling firm, operating out of Woodcliff Lake, NJ. Federal records list the affected scope as 19,660 vials.
The documented reason for this recall is: A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified. Distribution data in the federal record shows the product reached: New Jersey. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
19,660 vials
Related Recalls
6
5 from same agency
Product description
Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA
Reason for recall
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-1429-2012 |
| Date reported | August 8, 2012 |
| Date initiated | December 2, 2011 |
| Recalling firm | Eagle Pharmaceuticals Inc. |
| Firm location | Woodcliff Lake, NJ |
| Affected scope | 19,660 vials |
| Distribution | New Jersey |
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-1429-2012) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA. Recalled by Eagle Pharmaceuticals Inc.. Units affected: 19,660 vials.
Why was this product recalled? ▼
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 8, 2012. Severity: Critical. Recall number: D-1429-2012.
Where was the recalled product distributed? ▼
Distribution: New Jersey.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1429-2012) 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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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 August 8, 2012. 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.