FDA-Drug2021-02-10Class III
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01
Lupin Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Sold states
Nationwide
Affected count
46,479 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0247-2021Don't want to check this manually?
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