Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count 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.
Reported: June 8, 2016 Initiated: March 11, 2016 #D-0952-2016
Product Description
Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count 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.
Reason for Recall
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 7908 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count 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.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 7908 vials.
Why was this product recalled? ▼
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 8, 2016. Severity: Low. Recall number: D-0952-2016.
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