Drug recall D-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
Reason for recall
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Lots and codes
Lot # A906423, exp. date Nov 2021.
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 46,479 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 21, 2021
- Terminated
- December 16, 2021
Related products
- Oseltamivir phosphate – drug information
- NDC 68180-678 Oseltamivir Phosphate · Oseltamivir Phosphate 6 mg/mL · Lupin Pharmaceuticals, Inc.