Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported August 28, 2013
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Fresenius Kabi USA LLC (Fk USA) recalled IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only… - a moderate-severity action.
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only… was recalled by Fresenius Kabi USA LLC (Fk USA) in August 28, 2013. Reason: Crystallization: Active pharmaceutical ingredient is precipitating in product solution.. Check the official notice for the remedy. Verify recall #D-915-2013 with the FDA Drug before acting.
The recall
Fresenius Kabi USA LLC (Fk USA) issued this moderate-severity FDA Drug recall-Crystallization: Active pharmaceutical ingredient is precipitating in product solution..
- Moderate
- severity level
- Class II
- classification
- August 28, 2013
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-915-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-915-2013) was formally reported on August 28, 2013, with the manufacturer initiating the action on January 22, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Fresenius Kabi USA LLC (Fk USA) is listed as the recalling firm, operating out of Schaumburg, IL. Federal records list the affected scope as 23,672 vials.
The documented reason for this recall is: Crystallization: Active pharmaceutical ingredient is precipitating in product solution. Distribution data in the federal record shows the product reached: Nationwide. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
23,672 vials
Related Recalls
6
5 from same agency
Product description
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
Reason for recall
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-915-2013 |
| Date reported | August 28, 2013 |
| Date initiated | January 22, 2013 |
| Recalling firm | Fresenius Kabi USA LLC (Fk USA) |
| Firm location | Schaumburg, IL |
| Affected scope | 23,672 vials |
| Distribution | Nationwide |
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-915-2013) 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? ▼
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.. Recalled by Fresenius Kabi USA LLC (Fk USA). Units affected: 23,672 vials.
Why was this product recalled? ▼
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 28, 2013. Severity: Moderate. Recall number: D-915-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-915-2013) 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 28, 2013. 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.