Tuesday, November 23, 2021
Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Levetiracetam Injection, USP Due to Lack of Sterility Assurance
Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
- Lack of sterility assurance
- Company Name:
- Sagent Pharmaceuticals, Inc.
- Brand Name:
- Sagent
- Product Description:
- Levetiracetam Injection
Company Announcement
CHICAGO, IL – November 19, 2021 - Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of four lots of Levetiracetam Injection, USP, to the user level. The lack of container closure integrity, found in reserve sample vials may result in a non-sterile product.
Risk Statement: Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life threatening. To date, Sagent has not received reports of any product complaints or adverse events associated with this issue.
Levetiracetam Injection, USP 500 mg per 5 mL, is used in the treatment of certain types of seizures and is packaged in a 5mL single-does vial. The Levetiracetam Injection, USP, label and affected lot numbers with Expiration Dates and NDC number can be found in the table below. Product was distributed Nationwide from March to November 2021.
Product | Lot | Expiration Date | NDC Number | Distribution Dates |
|---|---|---|---|---|
| Levetiracetam Injection, USP | B0G85VB | Jun-2022 | 25021- 780-05 | May 2021 - August 2021 |
| B0K88VA | Sep-2022 | March 2021 - November 2021 | ||
| B0K89VA | Sep-2022 | August 2021 - November 2021 | ||
| B1G194A | Jun-2023 | October 2021 |
Sagent Pharmaceuticals, Inc. is notifying customers by fax, email, FedEx, and/or certified mail, which includes arrangements for return of all recalled product. Customers that have Levetiracetam Injection, USP 500mg per 5 mL, which is being recalled, have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return as directed the recalled lots of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. Healthcare/distributors/retailers that have product which is being recalled should stop using product and return the recalled product. The necessary form to document product information, as well as other information regarding this recall, is available at www.Sagentpharma.com.
Consumers or healthcare workers with any questions regarding this recall can contact the customer call center (866) 625-1618 M-F, 8am-7pm CST. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
- Consumers:
- Customer Call Center
- (866) 625-1618
Product Photos
"Nov. 2, 2021: Update – In October 2020, FDA was sued by seven compounding pharmacies in the U.S. District Court for the District of Columbia regarding the final standard Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products. In September 2021, the Court remanded the MOU to FDA to either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis. FDA is evaluating the Court’s decision.
Before the Court’s decision, FDA extended the period before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that do not sign the final standard MOU, to October 27, 2022.
FDA plans to provide additional updates, as appropriate, with regard to the MOU."
quoted from https://www.fda.gov/drugs/human-drug-compounding/memorandum-understanding-addressing-certain-distributions-compounded-drugs
Monday, November 22, 2021
Court Enjoins California Company from Manufacturing and Distributing Adulterated Sterile Animal Drugs
A federal court enjoined a California company from distributing adulterated sterile animal drugs in violation of the Federal Food, Drug and Cosmetic Act (FDCA), the Department of Justice announced.
In a complaint filed on Oct. 27, 2020 in the Central District of California, the United States alleged that multiple inspections by the U.S. Food and Drug Administration (FDA) repeatedly showed that Med-Pharmex Inc. (MPX) manufactured and distributed animal drugs under conditions that fell short of the minimum regulatory requirements to ensure safety and quality, including a failure to maintain sterility. According to the complaint, the FDA issued a warning letter to MPX in 2017 regarding numerous deficiencies found at the company. The complaint further alleged that the company failed to adequately investigate reports regarding the death or illness of animals receiving certain MPX drugs, and failed to properly clean and disinfect areas used to manufacture sterile drugs, as required by the FDCA. MPX and company president Gerald P. Macedo agreed to settle the suit and to be bound by a consent decree of permanent injunction that resolves the case.
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Saturday, November 20, 2021
Thursday, November 18, 2021
| Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine | Division of Pharmaceutical Quality Operations Division III | Compounding Pharmacy/Adulterated Drug Products |
| Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine | Division of Pharmaceutical Quality Operations Division III | Compounding Pharmacy/Adulterated Drug Products |
Wednesday, November 10, 2021
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Prosecutors say Houston-based Professional Compounding Centers of America Inc knowingly reported inflated average wholesale prices for its ingredients.
Justice Department accuses drug company of inflating prices
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