Multi-event November 2015 FDA Recall Drug by Remedyrepack Inc.

This Multi-event Class II drug recall was voluntarily initiated by Remedyrepack Inc. on November 11, 2015 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0516-2016 TERMINATED D-0514-2016 TERMINATED D-0512-2016 TERMINATED D-0513-2016 TERMINATED D-0515-2016 TERMINATED D-0517-2016 TERMINATED D-0511-2016 TERMINATED

Recall Number: D-0516-2016

Reason for Recall
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Initiated
11-11-2015
Reported
12-16-2015
Quantity
106 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72699
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.
RemedyRepack 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-01-2016
Product Description About Product Description
Full technical description of the product.
Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-2880, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0414-01

Batch or Lot Expiration Information

Lot# :QM114CZF0496, Exp 01/2016; B0025373-050514, B0029738-060914, Exp 02/2016; B0029737-060914, Exp 03/2016.

Recall Number: D-0514-2016

Reason for Recall
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Initiated
11-11-2015
Reported
12-16-2015
Quantity
1 Vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72699
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.
RemedyRepack 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-01-2016
Product Description About Product Description
Full technical description of the product.
Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0431-16

Batch or Lot Expiration Information

Lot# B0105052-100715, Exp 07/01/2017

Recall Number: D-0512-2016

Reason for Recall
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Initiated
11-11-2015
Reported
12-16-2015
Quantity
60 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72699
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.
RemedyRepack 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-01-2016
Product Description About Product Description
Full technical description of the product.
Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma Inc., Bristol, TN 37620, Repackaged by: RemedyRepack, Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0253-03

Batch or Lot Expiration Information

Lot# B0077329-040215, Exp 07/2017; B0091342-070315, Exp 08/2017; B0109416-102815, Exp 03/2018

Recall Number: D-0513-2016

Reason for Recall
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Initiated
11-11-2015
Reported
12-16-2015
Quantity
1 Vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72699
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.
RemedyRepack 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-01-2016
Product Description About Product Description
Full technical description of the product.
Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0873-02

Batch or Lot Expiration Information

Lot# B0105037-100715, Exp 10/01/2016

Recall Number: D-0515-2016

Reason for Recall
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Initiated
11-11-2015
Reported
12-16-2015
Quantity
1625 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72699
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.
RemedyRepack 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-01-2016
Product Description About Product Description
Full technical description of the product.
Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0316-01

Batch or Lot Expiration Information

Lot# : B0085124-051915, B0086919-052815, Exp 12/01/2016; B0089280-061215, B0090023-061915, B0089996-061915, B0091581-070715, B0091564-070715, B0091515-070715, Exp 01/01/2017; B0094980-080415, B0094965-080415, B0097515-082415, B0100639-091415, B0100611-091415, Exp 03/01/2017; B0100933-091515, B0107165-101915, B0107118-101915, Exp 06/01/2017.

Recall Number: D-0517-2016

Reason for Recall
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Initiated
11-11-2015
Reported
12-16-2015
Quantity
4 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72699
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.
RemedyRepack 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-01-2016
Product Description About Product Description
Full technical description of the product.
Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0222-57

Batch or Lot Expiration Information

Lot# : B0073852-030915, Exp 04/2016

Recall Number: D-0511-2016

Reason for Recall
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Initiated
11-11-2015
Reported
12-16-2015
Quantity
65 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72699
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.
RemedyRepack 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-01-2016
Product Description About Product Description
Full technical description of the product.
Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis, IN 46285, Repackaged by: Remedy Repack, Inc, 625 Kolter Dr, Indiana, PA 15701, NDC 52125-0415-08

Batch or Lot Expiration Information

Lot# B0080702-042715, B0080695-042715, B0097444-082015, Exp 07/2017; B0097443-082015, Exp 02/2018.