Reported Jan 13, 2021 · Terminated
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b)…
Ascend Laboratories LLC
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: Ascend Laboratories LLC · 339 Jefferson Rd Ste 101 · Parsippany, NJ · 07054-3707
Is this the product you have?
- Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only
- Manufactured byAlkem Laboratories, Ltd, Mumbai -400 013 INDIA
- Distributed byAscend Lab,oratories, LLC Parsippany, NJ 07054
- Lot codes and dates
Lot#: a) 1914434019144341Exp AUG 2021b) 2014222620142227Exp MAY 2022
- Amount recalled
- 20,232 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
This product could cause temporary or reversible health problems — stop using it.
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