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Medication Safety Alerts

Ceftriaxone for Injection Voluntary Recall

January 16, 2019

On January 16, 2019, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I recall of ceftriaxone for injection manufactured by Lupin Pharmaceuticals.This recall was issued because of product complaints of grey flecks in reconstituted vials. If the vial stopper is not properly pierced or if a needle greater than 21 gauge (larger internal diameter) is used, rubber flecks may be pushed into the solution. These rubber flecks may cause serious side effects.

This may represent a potential safety risk to plan members who may be using product affected by this recall.

A complete list of the affected products and lot numbers is provided here:

To see if your product is dispensed affected by this recall, please check the lot number. The lot number is on each vial on the right-hand side manufacturer’s label by the bar codes. If your product is not from one of these affected lots, it is not affected by this recall. If your product is from one of these affected lots, please contact the pharmacy that filled your prescription for more information including return instructions.

You should not continue to use product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response: These products are not carried by the CVS Caremark Mail Service Pharmacies. Please call a Customer Care representative toll-free at 1-866-823-5184 for more information.

If you are currently taking ceftriaxone for injectionand have questions regarding this recall, please call your doctor or call Lupin Pharmaceuticals Customer Service toll-free at 1‑866-587-4617 or visit www.lupinpharmaceuticals.com.

You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332).

For more information regarding Ceftriaxone for Injection 250 mg, please click on the link below:

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=169899

For more information regarding Ceftriaxone for Injection 500 mg, please click on the link below:

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=169901

For more information regarding Ceftriaxone for Injection 1 g, please click on the link below:

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=169902

For more information regarding Ceftriaxone for Injection 2 g, please click on the link below:

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=169903

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