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Class II: temporary or reversible health riskTerminated

Ascend Laboratories Cefixime Capsules Recall

Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratori…

Ascend Laboratories, LLC · Parsippany, NJ

Risk level
Class II
Reported by FDA
Jan 12, 2022
Recall ID
D-0359-2022
Check your lot numberHow we source this data

Summary

Ascend Laboratories recalled Cefixime Capsules starting Dec 21, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0359-2022 on Jan 12, 2022. Reason: Failed impurities/degradation specifications. Status: Terminated.

Why it was recalled

Failed impurities/degradation specifications

Product description

Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50

Lot numbers, UPCs & expiration codes

Lot #: 20140293, Exp Dec 2021; 20141525, 20141526, 20141527, Exp Mar 2022; 20143019, 20143020, 20143021, 20143022, Exp July 2022; 20144759, 20144760, 20144761, Exp Nov 22

Where it was sold

USA 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-0359-2022
Classification
Class II
Status
Terminated
Recall initiated
Dec 21, 2021
FDA report date
Jan 12, 2022
Quantity
42,698 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Ascend Laboratories, LLC

Original FDA data

Every field from FDA enforcement report D-0359-2022, exactly as published.

Show all FDA fields
City
Parsippany
State
NJ
Status
Terminated
Country
United States
Event ID
89259
Address
339 Jefferson Rd Ste 101
Code information
Lot #: 20140293, Exp Dec 2021; 20141525, 20141526, 20141527, Exp Mar 2022; 20143019, 20143020, 20143021, 20143022, Exp July 2022; 20144759, 20144760, 20144761, Exp Nov 22
Postal code
07054-3707
Report date
Jan 12, 2022
Product type
Drugs
Recall number
D-0359-2022
Classification
Class II
Recalling firm
Ascend Laboratories, LLC
Product quantity
42,698 bottles
Termination date
Apr 13, 2023
Reason for recall
Failed impurities/degradation specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50
Distribution pattern
USA nationwide.
Recall initiation date
Dec 21, 2021
Initial firm notification
Letter
Center classification date
Jan 5, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0359-2022, published Jan 12, 2022. 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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