Cefdinir Powder, For Suspension
FDA Recall NDC 0093-4136
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 Cefdinir (NDC 0093-4136). A significant event, classified as Class II, was initiated on Feb 26, 2013 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Defective Container: This recall is being carried out due to the potential for improperly sealed bottles."
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
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
Feb 26, 2013
Apr 17, 2013
62,187 bottles
Recall Profile & Regulatory Data
Event ID
64480
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jan 15, 2014
Product Description
Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960.
Batch or Lot Expiration Information
Lot# a)
Lot# : 30304253A, Exp 12/13; b)
Lot# : 30304144A, Exp 12/13 and 30304477A, Exp 03/14
Affected Packages Involved in this Recall
0093-4136-64Product
0093-4136-73Product
0093-4137-64Product
0093-4137-73Product
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.
