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
Reported: February 10, 2021 Initiated: January 21, 2021 #D-0247-2021
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.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 46,479 bottles
- Distribution
- Nationwide
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 46,479 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 10, 2021. Severity: Low. Recall number: D-0247-2021.
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