Multi-event February 2015 FDA Recall Colistimethate Sodium by Heritage Pharmaceuticals, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Heritage Pharmaceuticals, Inc. on February 25, 2015 for the product Colistimethate Sodium. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0416-2015
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
02-25-2015
03-25-2015
24,344 vials
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.
Heritage Pharmaceuticals, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
02-26-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31
Batch or Lot Expiration Information
Lot# VRIA002; Exp. 08/16, VRIA003; Exp. 09/16, VRIA004; Exp. 09/16
Recall Number: D-0415-2015
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
02-25-2015
03-25-2015
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.
Heritage Pharmaceuticals, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
02-26-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31
Batch or Lot Expiration Information
Lot# VCOA002; Exp. 09/14, VCOA003; Exp. 10/14, VCOA004; Exp. 10/14 VCOA005; Exp. 01/15, VCOA006; Exp 03/15, VCOA007; Exp 09/15, VCOA008; Exp. 12/15, VCOA009; Exp. 02/16, VCOA010; Exp. 10/16 VCOA011; Exp. 10/16
