Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.
Reported: January 16, 2019 Initiated: December 20, 2018 #D-0358-2019
Product Description
Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.
Reason for Recall
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 3,792 boxes
- Distribution
- Nationwide in the USA and Puerto Rico.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 3,792 boxes.
Why was this product recalled? ▼
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 16, 2019. Severity: Critical. Recall number: D-0358-2019.
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