Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceutic
Summary
The FDA issued a Class I for Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Via by Sagent Pharmaceuticals. Reason: Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product..
Details
Source
Drug Recall
External ID
D-0553-2024
Action Date
2024-06-19
Status
Ongoing
Category
drug
Product Description
Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
Lot/Code Info: Lot #: F1040001, Exp. Date 12/31/2024
Quantity Affected: 762 vials
Reason for Recall
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Distribution
Nationwide within the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-28
Company
Schaumburg, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 49 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Sagent Pharmaceuticals has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sagent Pharmaceuticals) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sagent Pharmaceuticals have FDA actions?
Sagent Pharmaceuticals has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0553-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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