PlainRecalls
FDA Drug Moderate Class II Terminated

Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68

Reported: January 6, 2021 Initiated: December 17, 2020 #D-0179-2021

Product Description

Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68

Reason for Recall

Failed Impurity/Degradation Specifications

Details

Recalling Firm
Ascend Laboratories LLC
Units Affected
9,524 bottles
Distribution
Nationwide
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68. Recalled by Ascend Laboratories LLC. Units affected: 9,524 bottles.
Why was this product recalled?
Failed Impurity/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on January 6, 2021. Severity: Moderate. Recall number: D-0179-2021.