Reported Feb 6, 2019 · Terminated
Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore,…
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?
- Cephalexin for Oral Suspension USP 250mg/5 mL
- Rx Only Manufactured forLupin Pharmaceuticals, Inc., Baltimore, Maryland
- Manufactured byLupin Limited Mandideep 462 046 India --- NDC 68180-441-01
- Lot codes and dates
lot F801282Expiry June 2020
- Amount recalled
- 14,400 bottles
Why it was recalled
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
This product could cause temporary or reversible health problems — stop using it.
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