Reported Jan 16, 2019 · Terminated
Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx…
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. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174
Is this the product you have?
Cefdinir for Oral Suspension USP125mg/5mLpackaged in a) 60mL (NDC 68180-722-20)b)100mL (NDC 68180-722-10)Rx Only
- Manufactured forLupin Pharmaceuticals Inc. Baltimore, MD 21202
- Manufactured byLupin Limited Mandideep 462 046 INDIA
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 F700329, F700330, F700328, Exp. January 2019 2 F700544, F700545, F700668, F700669, F700670, Exp. March 2019 3 F700958, Exp. April 2019 b) Lot #: F700327, F700392, F700393, Exp. January 2019 4 F700546, F700547, F700664, Exp. March 2019 5 F700967, Exp. April 2019, F701106, F701107, F701108, F701109, Exp. May 2019. - Amount recalled
- 287,784 bottles
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
This product could cause temporary or reversible health problems — stop using it.
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