Recalls / Class III
Class IIID-0247-2021
Product
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
- Brand name
- Oseltamivir Phosphate
- Generic name
- Oseltamivir Phosphate
- Active ingredient
- Oseltamivir Phosphate
- Route
- Oral
- NDC
- 68180-678
- FDA application
- ANDA208347
- Affected lot / code info
- Lot # A906423, exp. date Nov 2021.
Why it was recalled
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 46,479 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-01-21
- FDA classified
- 2021-02-03
- Posted by FDA
- 2021-02-10
- Terminated
- 2021-12-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0247-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.