Multi-event June 2015 FDA Recall Drug by Vital Care Compounder

This Multi-event Class II drug recall was voluntarily initiated by Vital Care Compounder on June 10, 2015 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in MS and the recall is currently terminated.

Reported Recall Events

D-1055-2016 TERMINATED D-1054-2016 TERMINATED D-1056-2016 TERMINATED

Recall Number: D-1055-2016

Reason for Recall
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Initiated
06-10-2015
Reported
07-06-2016
Quantity
9 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74539
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.
Vital Care Compounder
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MS
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-17-2016
Product Description About Product Description
Full technical description of the product.
Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS

Batch or Lot Expiration Information

Lot# : 395575, Use by 07-27-2016

Recall Number: D-1054-2016

Reason for Recall
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Initiated
06-10-2015
Reported
07-06-2016
Quantity
39 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74539
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.
Vital Care Compounder
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MS
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-17-2016
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS

Batch or Lot Expiration Information

Lot# : 389279, Use by 09-09-16

Recall Number: D-1056-2016

Reason for Recall
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Initiated
06-10-2015
Reported
07-06-2016
Quantity
54 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74539
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.
Vital Care Compounder
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MS
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-17-2016
Product Description About Product Description
Full technical description of the product.
Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS

Batch or Lot Expiration Information

Lot# : 391462, Use by 10-06-2016