Reported Feb 24, 2021 · Terminated
Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories,…
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 250 mg per 5 mL 200 ml (when mixed) Rx Only
- Manufactured byAlkem Laboratories, Ltd
- Mumbai -400 013 INDIA Distributed byAscend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68
- Lot codes and dates
Lot #: 1914186919141870EXP 3/202119142762EXP 5/202119143826191439231914394119143954 EXP 7/2021
- Amount recalled
- 23,436 200 mL bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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