Recalls / Class III
Class IIID-0951-2016
Product
Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), 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) C500031, Exp 12/17; b) C500026, Exp 12/17; C500036, C500043, Exp 01/18
Why it was recalled
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 15408 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-03-11
- FDA classified
- 2016-06-02
- Posted by FDA
- 2016-06-08
- Terminated
- 2017-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0951-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.