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  4. Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g
  1. Recalls, Market Withdrawals, & Safety Alerts


Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

This recall has been completed and FDA has terminated this recall.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Company Announcement Date:
FDA Publish Date:
Product Type:
Generic Drugs
Reason for Announcement:
Recall Reason Description
Foreign Material
Company Name:
Lupin Pharmaceuticals, Inc.
Brand Name:
Brand Name(s)
Lupin Pharmaceuticals, Inc.
Product Description:
Product Description
Ceftriaxone for Injection, USP

Company Announcement

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

Improper piercing and use of a needle greater than 21 gauge (larger internal diameter), while reconstituting the vial, can push rubber flecks into the solution. There were no grey flecks seen prior to the reconstitution of the vials and the issue was identified upon standard visual inspection prior to patient administration.

If injected, this product (containing rubber particulate matter from the stopper) could cause vein irritation/phlebitis or pulmonary embolic events that could result in permanent impairment of body function or damage to body structures, such as the lungs and vascular system. In addition, as ceftriaxone can be administered intramuscularly, the use of the product may result in local muscle inflammation and/or abscesses.

Ceftriaxone for Injection, USP, is used as a sterile, semi-synthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. It is used to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone sodium and other antibacterial drugs Ceftriaxone for Injection, USP, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. To date, the Company has not received any reports of adverse events related to the recalled lots.

Ceftriaxone for Injection, USP, is packaged in a glass vial, in pack of 10, containing 10 vials in a carton, with NDC 68180-611-10, 68180-622-10, 68180-633-10, 68180-644-10 and as single pack containing one glass vial in a carton with NDC 68180-611-01, 68180-622-01, 68180-633-01.

The lots of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g included in the recall are listed in the table below:

Product Name NDC Lot Number Expiration Date
Ceftriaxone for Injection USP, 250mg 68180-611-10 C600182 09/2019
68180-611-10 C600136 08/2019
68180-611-01 C600142 08/2019
68180-611-10 C700147 05/2020
68180-611-10 C700207 09/2020
Ceftriaxone for Injection USP, 500mg 68180-622-01 C600218 09/2019
68180-622-10 C600219 09/2019
68180-622-10 C600126 08/2019
68180-622-10 C600127 08/2019
68180-622-10 C600137 08/2019
68180-622-10 C600143 08/2019
68180-622-01 C600173 08/2019
68180-622-10 C700146 05/2020
68180-622-10 C700208 09/2020
68180-622-10 C700209 09/2020
Ceftriaxone for Injection USP, 1g 68180-633-10 C600106 05/2019
68180-633-10 C600108 05/2019
68180-633-01 C600110 05/2019
68180-633-10 C600174 09/2019
68180-633-10 C600179 09/2019
68180-633-10 C600180 09/2019
68180-633-10 C600181 09/2019
68180-633-10 C700110 03/2020
68180-633-10 C700111 03/2020
68180-633-10 C700131 05/2020
68180-633-10 C700132 05/2020
68180-633-10 C700138 05/2020
68180-633-01 C700143 05/2020
68180-633-10 C600128 08/2019
68180-633-01 C600130 08/2019
68180-633-10 C600138 08/2019
68180-633-10 C700108 03/2020
68180-633-10 C700109 03/2020
68180-633-10 C700112 03/2020
68180-633-10 C700129 05/2020
68180-633-10 C700130 05/2020
68180-633-10 C700142 05/2020
68180-633-10 C700145 05/2020
68180-633-01 C700113 03/2020
Ceftriaxone for Injection USP, 2g 68180-644-10 C600109 05/2019
68180-644-10 C600129 08/2019
68180-644-10 C600135 08/2019

Ceftriaxone for Injection, USP, 250mg, Ceftriaxone for Injection, USP, 500mg, Ceftriaxone for Injection, USP, 1g and Ceftriaxone for Injection, USP, 2g were distributed Nationwide to Wholesalers / Drug chains.

Lupin Pharmaceuticals Inc. is notifying its distributors by phone and through recall notification and is arranging for return of all recalled product lots.

Hospitals / Physicians that have Ceftriaxone for Injection, USP, which are being recalled should stop using and return to Genco Pharmaceuticals Services “a subsidiary of FedEx Supply Chain” 6101 North 64th Street, Milwaukee, WI 53218, Tel: (855) 838-5786.

Questions regarding this recall can be made by contacting GENCO Pharmaceutical Services at 1-855-838-5786 Monday – Friday 7:30 am to 6:00 pm EST. For reimbursement, please have the recalled lots returned to GENCO, the lot number can be found on the side of the vial. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact Information

Pooja Thakran
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