Ceftriaxone Injection (Lupin) – Rubber Particulate Matter (2018)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Brand
Lupin Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Lot #: a) C600173, Exp 08/19, C600218, Exp 09/19, b) C600126, C600127, C600137, C600143, Exp 08/19, C600219, Exp 09/19, C700146, Exp 05/20, C700208, C700209, Exp 09/20.
Products Sold
Lot #: a) C600173, Exp 08/19; C600218, Exp 09/19; b) C600126, C600127, C600137, C600143, Exp 08/19; C600219, Exp 09/19; C700146, Exp 05/20; C700208, C700209, Exp 09/20.
Lupin Pharmaceuticals Inc. is recalling Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) due to Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026