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Class III: unlikely to cause harmTerminated

Renaissance Lakewood Fluconazole Injection Recall

Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33…

Renaissance Lakewood, LLC · Lakewood, NJ

Risk level
Class III
Reported by FDA
Dec 27, 2017
Recall ID
D-0124-2018
Check your lot numberHow we source this data

Summary

Renaissance Lakewood recalled Fluconazole Injection starting Nov 11, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0124-2018 on Dec 27, 2017. Reason: Superpotent. Status: Terminated.

Why it was recalled

Superpotent

Product description

Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India

Lot numbers, UPCs & expiration codes

a) A060174 01/13/2018, A060257 02/28/2018, A060692 05/31/2018, A061165 09/30/2018, A0A0143 01/31/2019, A0A0347 03/31/2019, and A0A0424 04/30/2019 ; b) A060027 12/31/2017

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-0124-2018
Classification
Class III
Status
Terminated
Recall initiated
Nov 11, 2017
FDA report date
Dec 27, 2017
Quantity
24,569 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Renaissance Lakewood, LLC

Original FDA data

Every field from FDA enforcement report D-0124-2018, exactly as published.

Show all FDA fields
City
Lakewood
State
NJ
Status
Terminated
Country
United States
Event ID
78504
Address
1200 Paco Way
Code information
a) A060174 01/13/2018, A060257 02/28/2018, A060692 05/31/2018, A061165 09/30/2018, A0A0143 01/31/2019, A0A0347 03/31/2019, and A0A0424 04/30/2019 ; b) A060027 12/31/2017
Postal code
08701-5938
Report date
Dec 27, 2017
Product type
Drugs
Recall number
D-0124-2018
Classification
Class III
Recalling firm
Renaissance Lakewood, LLC
Product quantity
24,569 bags
Termination date
Apr 1, 2020
Reason for recall
Superpotent
Voluntary / mandated
Voluntary: Firm initiated
Product description
Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India
Distribution pattern
Nationwide
Recall initiation date
Nov 11, 2017
Initial firm notification
Letter
Center classification date
Dec 20, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0124-2018, published Dec 27, 2017. 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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