May 2019 FDA Recall Cefdinir by Lupin Pharmaceuticals Inc.
D-1320-2019 - Complaint received of metal piece identified in the product bottle prior to the reconstitution.

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on May 23, 2019 for the product Cefdinir. The FDA reported the reason for recall as complaint received of metal piece identified in the product bottle prior to the reconstitution.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1320-2019

Reason for Recall
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Initiated
05-23-2019
Reported
06-05-2019
Quantity
18,408, 60 mL bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82939
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.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-22-2020
Product Description About Product Description
Full technical description of the product.
Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20

Batch or Lot Expiration Information

Lot# F802335, exp. date November 2020

Affected Packages Involved in this Recall

68180-722-20 Cefdinir
68180-722-10 Cefdinir
68180-722-04 Cefdinir
68180-722-05 Cefdinir
68180-723-20 Cefdinir
68180-723-10 Cefdinir
68180-723-04 Cefdinir
68180-723-05 Cefdinir