Multi-event July 2016 FDA Recall Drug by Pharmacy Plus, Inc. Dba Vital Care Compounder

This Multi-event Class II drug recall was voluntarily initiated by Pharmacy Plus, Inc. Dba Vital Care Compounder on July 26, 2016 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-1537-2016 TERMINATED D-1542-2016 TERMINATED D-1533-2016 TERMINATED D-1548-2016 TERMINATED D-1546-2016 TERMINATED D-1544-2016 TERMINATED D-1530-2016 TERMINATED D-1543-2016 TERMINATED D-1531-2016 TERMINATED D-1539-2016 TERMINATED D-1541-2016 TERMINATED D-1529-2016 TERMINATED D-1535-2016 TERMINATED D-1540-2016 TERMINATED D-1547-2016 TERMINATED D-1532-2016 TERMINATED D-1538-2016 TERMINATED D-1545-2016 TERMINATED D-1536-2016 TERMINATED D-1534-2016 TERMINATED D-1549-2016 TERMINATED

Recall Number: D-1537-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
14 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# 396817, Use by 09/13/16

Recall Number: D-1542-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
6 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial, Rx, Vital Care Compounder, Hattiesburg, MS

Batch or Lot Expiration Information

Lot# 397267, Use by 9/20/16

Recall Number: D-1533-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
6 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# : 399080, Use by 8-14-16; 399740, Use by 8-25-16; 398952, Use by 8-13-16; 398865, Use by 8-11-16; 399057, Use by 8-13-16; 398864, Use by 8-11-16

Recall Number: D-1548-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
23 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# 398178, Use by 12/30/16

Recall Number: D-1546-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS

Batch or Lot Expiration Information

Lot# 389278, Use by 8-9-16

Recall Number: D-1544-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
139 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS

Batch or Lot Expiration Information

Lot# : 365204, Use by 8/1/16 and 384395, Use by 3/12/17

Recall Number: D-1530-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
5 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compounder, Hattiesburg, MS

Batch or Lot Expiration Information

Lot# 396691, Use by 09-13-16

Recall Number: D-1543-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
6 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS

Batch or Lot Expiration Information

Lot# 397269, Use be 9/20/16

Recall Number: D-1531-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS

Batch or Lot Expiration Information

Lot# 397876, Use by 10-27-16

Recall Number: D-1539-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS

Batch or Lot Expiration Information

Lot# 396689, Use by 12-13-16

Recall Number: D-1541-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
8 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# : 390325, Use by 08/01/16; 382789, Use by 08/07/16; 396766, Use by 08/11/16; 393470, Use by 08/14/16; 393036, Use by 08/14/16; 398131, Use by 08/15/16; 389288, Use by 08/20/16; 392969, Use by 08/21/16

Recall Number: D-1529-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
108 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# 373003, 381408, Use by 02-11-17

Recall Number: D-1535-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
386606 - 3 vials, 393302 - 3 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# : 386606, Use by 8-9-16, 393302, Use by 10-28-16

Recall Number: D-1540-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
36 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# 396814, Use by 12-14-16

Recall Number: D-1547-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
1vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5.9ml solution, Rx, Vital Care Compounder, Hattiesburg, MS

Batch or Lot Expiration Information

Lot# 397877, USE BY 1-6-17

Recall Number: D-1532-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/ml, Dexamethasone Sodium Phosphate 1mg/ml, Rx only, For ophthalmic use only, Vital Care Compounder, Hattiesburg, MS

Batch or Lot Expiration Information

Lot# 396627, Use by 8-10-16

Recall Number: D-1538-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
16 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital Care Compounder, Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# 396607, Use by 08/13/16

Recall Number: D-1545-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# 397877, USE BY 1-6-17

Recall Number: D-1536-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
62 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# 396770, Use by 09-13-16

Recall Number: D-1534-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
3 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compounder, Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# 386184, Use by 08-03-16

Recall Number: D-1549-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-26-2016
Reported
10-05-2016
Quantity
6 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75164
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.
Pharmacy Plus, Inc. dba 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.
11-18-2016
Product Description About Product Description
Full technical description of the product.
DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg, MS

Batch or Lot Expiration Information

Lot# 389321, Use by 3/10/17