Drug 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
D-0247-2021
Product summary
- Event
- Event 87195
- Status
- Terminated
- Classification
- Class III
- Quantity
- 46,479 bottles
- Official record key
drug-enforcement:D-0247-2021
Official wording
Reason: Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Code information: Lot # A906423, exp. date Nov 2021.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out-of-specification