D-0247-2021 Class III Terminated
FDA drug recall D-0247-2021 was initiated by Lupin Pharmaceuticals Inc. on January 21, 2021 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point. The recall status is terminated (terminated December 16, 2021). Affected quantity: 46,479 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 10, 2021
- Initiation Date
- January 21, 2021
- Termination Date
- December 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46,479 bottles
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lot # A906423, exp. date Nov 2021.