Recalls / Class I
Class ID-0356-2019
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, 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.
- Affected lot / code info
- 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.
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) 8,000 vials; b) 32,045 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-0356-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.