Reported Feb 10, 2021 · Terminated
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174
Is this the product you have?
- Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only
- Manufactured forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
- Manufactured byLupin Limited Aurangabad, Maharashtra, India
- NDC68180-678-01
- Lot codes and dates
Lot # A906423exp. date Nov 2021
- Amount recalled
- 46,479 bottles
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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