Cefprozil Powder, For Suspension
FDA Recall NDC 68180-402
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cefprozil (NDC 68180-402). A significant event, classified as Class II, was initiated on Mar 26, 2021 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Superpotent Drug"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Superpotent Drug
Mar 26, 2021
Apr 21, 2021
a) 6,816 bottles; b) 3,960 bottles and c) 7,038 bottles
Recall Profile & Regulatory Data
Event ID
87602
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Dec 16, 2021
Product Description
Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only, Manufactured for: Lupin Pharmaceutical, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Mandideep 462 046, India.
Batch or Lot Expiration Information
Lot# Lot Numbers: a) F801122, exp. date June 2021; b) F801123, exp. date June 2021; c) F801124, exp. date June 2021
Affected Packages Involved in this Recall
68180-401-03Product
68180-401-01Product
68180-401-02Product
68180-402-01Product
68180-402-03Product
68180-402-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
