Recalls / Class I
Class ID-0357-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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.
- Affected lot / code info
- Lot #: a) C600110, Exp 05/19; C600130, Exp 08/19; C700113, Exp 03/20; C700143, Exp 05/20; b) C600106, C600108, Exp 05/19; C600128, C600138, Exp 08/19; C600174, C600179, C600180, C600181, Exp 09/19; C700108, C700109, C700110, C700111, C700112, Exp 03/20; C700129, C700130, C700131, C700132, C700138, C700142, C700145, Exp 05/20
Why it was recalled
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- a) 35,000 vials; b) 112,641 boxes
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2018-12-20
- FDA classified
- 2019-01-14
- Posted by FDA
- 2019-01-16
- Terminated
- 2020-08-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0357-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.