March 2021 FDA Recall Cefprozil by Lupin Pharmaceuticals Inc.
D-0332-2021 - Superpotent Drug

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on March 26, 2021 for the product Cefprozil. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0332-2021

Reason for Recall
Superpotent Drug
Initiated
03-26-2021
Reported
04-21-2021
Quantity
a) 6,816 bottles; b) 3,960 bottles and c) 7,038 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87602
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-16-2021
Product Description About Product Description
Full technical description of the product.
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

68180-401-03 Cefprozil
68180-401-01 Cefprozil
68180-401-02 Cefprozil
68180-402-01 Cefprozil
68180-402-03 Cefprozil
68180-402-02 Cefprozil