Reported Jan 16, 2019 · Terminated
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), 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 USP250mg/5mLpackaged in a) 60mL (NDC 68180-723-20)b)100mL (NDC 68180-723-10)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 F700343, F700344, F700345, F700346, F700347,F700376, F700377, F700415, F700146,F700417, F700418, Exp. Jan 2019 2 F700419, F700420, F700492, F700493,F700508,F700665, Exp. February 2019 3 F700784, Exp. April 2019 4 Lot #: F700324, F700325, F700326, Exp. January 2019 5 F700618, F700619, F700620, Exp. February 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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