February 2013 FDA Recall Cefdinir by Teva Pharmaceuticals Usa, Inc.
D-247-2013 - Defective Container
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on February 26, 2013 for the product Cefdinir. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-247-2013
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
02-26-2013
04-17-2013
62,187 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
01-15-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
