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Class II: temporary or reversible health riskTerminated

Ascend Laboratories Recall

Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (wh…

Ascend Laboratories LLC · Parsippany, NJ

Risk level
Class II
Reported by FDA
Jan 6, 2021
Recall ID
D-0178-2021
Check your lot numberHow we source this data

Summary

Ascend Laboratories recalled Ascend Laboratories starting Dec 17, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0178-2021 on Jan 6, 2021. Reason: Failed Impurity/Degradation Specifications. Status: Terminated.

Why it was recalled

Failed Impurity/Degradation Specifications

Product description

Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88

Lot numbers, UPCs & expiration codes

20141674, 20141675, 20141676, 20141677, 20141678,

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0178-2021
Classification
Class II
Status
Terminated
Recall initiated
Dec 17, 2020
FDA report date
Jan 6, 2021
Quantity
29,317 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Ascend Laboratories LLC

Original FDA data

Every field from FDA enforcement report D-0178-2021, exactly as published.

Show all FDA fields
City
Parsippany
State
NJ
Status
Terminated
Country
United States
Event ID
87032
Address
339 Jefferson Rd Ste 101
Code information
20141674, 20141675, 20141676, 20141677, 20141678,
Postal code
07054-3707
Report date
Jan 6, 2021
Product type
Drugs
Recall number
D-0178-2021
Classification
Class II
Recalling firm
Ascend Laboratories LLC
Product quantity
29,317 bottles
Termination date
May 3, 2023
Reason for recall
Failed Impurity/Degradation Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88
Distribution pattern
Nationwide
Recall initiation date
Dec 17, 2020
Initial firm notification
Letter
Center classification date
Dec 30, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0178-2021, published Jan 6, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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