Reported Jul 29, 2020 · Terminated
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin…
Lupin Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only
- Manufactured forLupin Pharmaceuticals, Inc., Baltimore, Maryland
- Manufactured byLupin Limited, Mandideep, India, NDC 68180-723-20
- Lot codes and dates
Lot # F802189Exp 10/2020F900240Exp 1/2021
- Amount recalled
- 35,928 bottles
Where it was sold
- Nationwide
Why it was recalled
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
This product could cause temporary or reversible health problems — stop using it.
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