Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Reported: January 16, 2019 Initiated: December 20, 2018 #D-0357-2019
Product Description
Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
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
- a) 35,000 vials; b) 112,641 boxes
- Distribution
- Nationwide in the USA and Puerto Rico.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: a) 35,000 vials; b) 112,641 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-0357-2019.
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