Multi-event May 2015 FDA Recall Drug by Lincare, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Lincare, Inc. on May 28, 2015 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in United States including: Arkansas and the recall is currently terminated.

Reported Recall Events

D-1185-2015 TERMINATED D-1195-2015 TERMINATED D-1159-2015 TERMINATED D-1180-2015 TERMINATED D-1184-2015 TERMINATED D-1168-2015 TERMINATED D-1202-2015 TERMINATED D-1170-2015 TERMINATED D-1173-2015 TERMINATED D-1153-2015 TERMINATED D-1187-2015 TERMINATED D-1152-2015 TERMINATED D-1157-2015 TERMINATED D-1177-2015 TERMINATED D-1192-2015 TERMINATED D-1164-2015 TERMINATED D-1186-2015 TERMINATED D-1160-2015 TERMINATED D-1188-2015 TERMINATED D-1167-2015 TERMINATED D-1205-2015 TERMINATED D-1194-2015 TERMINATED D-1175-2015 TERMINATED D-1158-2015 TERMINATED D-1174-2015 TERMINATED D-1190-2015 TERMINATED D-1189-2015 TERMINATED D-1191-2015 TERMINATED D-1165-2015 TERMINATED D-1171-2015 TERMINATED D-1179-2015 TERMINATED D-1193-2015 TERMINATED D-1161-2015 TERMINATED D-1163-2015 TERMINATED D-1199-2015 TERMINATED D-1196-2015 TERMINATED D-1172-2015 TERMINATED D-1178-2015 TERMINATED D-1204-2015 TERMINATED D-1169-2015 TERMINATED D-1203-2015 TERMINATED D-1181-2015 TERMINATED D-1166-2015 TERMINATED D-1201-2015 TERMINATED D-1183-2015 TERMINATED D-1176-2015 TERMINATED D-1156-2015 TERMINATED D-1200-2015 TERMINATED D-1162-2015 TERMINATED D-1197-2015 TERMINATED D-1154-2015 TERMINATED D-1155-2015 TERMINATED D-1198-2015 TERMINATED D-1182-2015 TERMINATED

Recall Number: D-1185-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
3 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
CIPROFLOXACIN 400MG / D5W 200ML ACCUFLO, Packaged in 3 200 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/28/2015, Discard After: 06/11/2015

Recall Number: D-1195-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
2 Syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Packaged in 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/27/2015, Discard After: 06/24/2015

Recall Number: D-1159-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
7 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
TPN 3:1, 3000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, MgSO4, KCL, NaC, Zinc Cl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# All product compounded between May 14, 2015 and May 27, 2015

Recall Number: D-1180-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
1 Bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Fluorouracil 4600mg / D5W 292 mL, Qty: 1 292 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/28/15, Discard After: 06/11/15

Recall Number: D-1184-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
3 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
CEFEPIME 1gm / NS 50mL AccuFlo, Packaged in 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/28/2015, Discard After: 06/11/2015

Recall Number: D-1168-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
1 Bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Fluorouracil 5760mg / D5W 265mL Qty: 1 265 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# Compounded on 05/27/15, Discard After: 06/10/15

Recall Number: D-1202-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
1 Bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
HYDROmorphone HCl PF, Hydromorphone 1000 mg / NS 500 mL, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/15, Discard After: 06/26/15

Recall Number: D-1170-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
1 Bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Fluorouracil 1400mg / D5W 278mL Qty: 1 278 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/15, Discard After: 06/12/15

Recall Number: D-1173-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
4 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
CEFTRIAXONE SODIUM 2000mg / NS 50mL, Qty:4 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/27/15; Discard After: 06/10/15

Recall Number: D-1153-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
5 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
TPN 3:1, 2250 mL Bags, Qty: 5, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, K Phos, Famotidine, Na Acetate, MgSO4; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# All product compounded between May 14, 2015 and May 27, 2015

Recall Number: D-1187-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
1 Bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Fentanyl Citrate, FENTANYL 25,000 MCG / 500 ML, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/15, Discard After: 06/26/15

Recall Number: D-1152-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
6 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
TPN 3:1, 2400 mL Bag, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj.; Electrolytes KCL, K Acetate, Na Acetate, K Phos, MgSO4; Vitamins, trace elements and medications Trace Ele. -Ped, Multi Vitamin, Rx Only, Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# All product compounded between May 14, 2015 and May 27, 2015

Recall Number: D-1157-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
2 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
TPN 3:1, 1800 ml Bags, Qty: 2, Base Formula NaCl 0.9%, Dextrose 70%, Travasol 10%, Intralipid 20%, Water; Electrolytes K Phos, Mag Sulfate, KCL, Ca Gluconate; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# All product compounded between May 14, 2015 and May 27, 2015

Recall Number: D-1177-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
1 Bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Fluorouracil 3200mg / D5W 264mL, Qty: 1 264 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/15, Discard After: 06/12/15

Recall Number: D-1192-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
3 Units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Vancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin 100u/mL, Qty: 3, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/27/15, Discard After: 06/10/15

Recall Number: D-1164-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
7 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
TPN 3:1, 1090 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Phos, KCL, MgSO4, NaCl, Ca Gluconate, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# All product compounded between May 14, 2015 and May 27, 2015

Recall Number: D-1186-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
8 Units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Vancomycin HCl / Heparin, Vancomycin 50mcg/ml / HEPARIN 100u/ml, Qty: 8, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/27/15, Discard After: 06/10/15

Recall Number: D-1160-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
7 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
TPN 3:1, 1440 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes Calcium Gluc, Na Phos, Na Acetate, MgSO4, K Acetate; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Folic Acid, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# All product compounded between May 14, 2015 and May 27, 2015

Recall Number: D-1188-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
7 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Vancomycin, VANCOMYCIN 750mg / NS 100mL AccuFlo, Qty: 7 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/28/15, Discard After: 06/11/15

Recall Number: D-1167-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
12 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Vancomycin HCl in Dextrose, VANCOMYCIN 500mg / D5W 100mL AccuFlo, Qty: 12 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/15, Discard After: 06/12/15

Recall Number: D-1205-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
7 Syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/27/15, Discard After: 06/24/15

Recall Number: D-1194-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assure
Initiated
05-28-2015
Reported
07-08-2015
Quantity
2 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Pfizerpen-G 4.2 MU / SW 240 mL AccuFlo, Packaged in 2 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/2015, Discard After: 06/12/2015

Recall Number: D-1175-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
1 Bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Fluorouracil 1200mg / D5W 274mL, Qty: 1 274 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/28/15, Discard After: 06/11/15

Recall Number: D-1158-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
7 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 10%, Water for Inj; Electrolytes Calcium Gluc, MgSO4, Na Phos, KCL; Vitamins, trace elements and medications Copper Cl, Selenium, Zinc Sulfate, Infuvite Pediat, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# All product compounded between May 14, 2015 and May 27, 2015

Recall Number: D-1174-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
1 Bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Fluorouracil 4800mg / D5W 296mL, Qty: 1 296 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/27/15, Discard After: 06/10/15

Recall Number: D-1190-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
2 Syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Diphenhydramine HCl, Diphenhydramine 25mg / NS 10 ml syringe, Qty: 2 10 mL syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/27/15, Discard After: 06/10/15

Recall Number: D-1189-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
12 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Ceftriaxone Sodium, Ceftriaxone 2gm / NS 50mL, Qty: 12 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/15, Discard After: 06/12/15

Recall Number: D-1191-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
2 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Vancomycin HCl, Vancomycin 1500mg / D5W 265mL, Qty: 2 265 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/10/15, Discard After: 06/10/15

Recall Number: D-1165-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
6 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
TPN 3:1, 1844 mL Bags, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, Ca Gluconate, MgSO4, K Phos; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# All product compounded between May 14, 2015 and May 27, 2015

Recall Number: D-1171-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
7 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
VANCOMYCIN 1.25gm / NS 250mL AccuFlo, Qty: 7 250 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/27/15, Discard After: 06/10/15

Recall Number: D-1179-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
12 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 12 150 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/15, Discard After: 06/12/15

Recall Number: D-1193-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured
Initiated
05-28-2015
Reported
07-08-2015
Quantity
14 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Cefepime HCl, Cefepime 2 gm / NS 100 mL AccuFlo, Qty: 14 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/27/15, Discard After: 06/10/15

Recall Number: D-1161-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
5 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
TPN 3:1, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, KCL, K Phos, Na Acetate, MgSO4, NaCl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# All product compounded between May 14, 2015 and May 27, 2015

Recall Number: D-1163-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
6 preparations

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
TPN 3:1, 1050 mL Bags, Qty: 6, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes KCL, K Phos, MgSO4, NaCl, Zinc Cl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# All product compounded between May 14, 2015 and May 27, 2015

Recall Number: D-1199-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
12 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Cefepime HCl, CEFEPIME 850 mg NS 50mL AccuFlo, Qty: 12 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/15, Discard After: 06/12/15

Recall Number: D-1196-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
2 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Vancomycin 750 mg/NS 100 ml accuflo, Packaged in 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/2015, Discard After: 06/12/2015

Recall Number: D-1172-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
6 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 6 150 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/15, Discard After: 06/10/15

Recall Number: D-1178-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
1 Bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
HYDROmorphone HCl PF, HYDROMORPHONE HCL 1000mg /NS 500mL, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/27/15, Discard After: 06/24/15

Recall Number: D-1204-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
6 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Ganciclovir Sodium, 250MG / NS 100ML, QTY: 6 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/15, Discard After: 06/12/15

Recall Number: D-1169-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
10 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
CefTRIAXone Sodium, Ceftriaxone 1 gram / NS 50 mL, Qty: 10 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/15, Discard After: 06/08/15

Recall Number: D-1203-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
1 Bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/15, Discard After: 06/12/15

Recall Number: D-1181-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
VANCOMYCIN HCL 250mg / NS 6mL syringe, Packaged in 6 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/27/2015, Discard After: 06/06/2015

Recall Number: D-1166-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
4 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo, Qty: 4 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# Compounded on 05/29/15, Discard After: 06/12/15

Recall Number: D-1201-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
15 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Ceftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/28/15, Discard After: 06/11/15

Recall Number: D-1183-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo, Packaged in 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/28/2015, Discard After: 06/11/2015

Recall Number: D-1176-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
1 Bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
FLUOROURACIL 1560MG / D5W 281ML, Qty: 1 281 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/26/15, Discard After: 06/09/15

Recall Number: D-1156-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
3 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
TPN 3:1, 997 ml without lipids Bags, Qty: 3, Base Formula Dextrose 70%, Travasol 10%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Infuvitm Pediat, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# All product compounded between May 14, 2015 and May 27, 2015

Recall Number: D-1200-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
1 Bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate, MORPHINE SULFATE 1000mg / NS 100mL, Qty: 1 50 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/30/15, Discard After: 06/13/15

Recall Number: D-1162-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
5 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
TPN 3:1, 817 mL Bags, Qty: 5, Base Formula Dextrose 70%, Trophamine 10%, Intralipid 20%, Water for Inj; Electrolytes K Phos, KCL, MgSO4, NaCl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# All product compounded between May 14, 2015 and May 27, 2015

Recall Number: D-1197-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Vancomycin 1000mg / NS 100mL, Packaged in 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/27/2015, Discard After: 06/10/2015

Recall Number: D-1154-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
7 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
TPN 3:1, 2000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes K Acetate, Na Acetate, Famotidine, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Salenium, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# All product compounded between May 14, 2015 and May 27, 2015

Recall Number: D-1155-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
4 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Rx Only. United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Batch or Lot Expiration Information

Lot# All product compounded between May 14, 2015 and May 27, 2015

Recall Number: D-1198-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
1 Bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
Potassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/28/15, Discard After: 06/11/15

Recall Number: D-1182-2015

Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Initiated
05-28-2015
Reported
07-08-2015
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71415
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.
Lincare, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including: Arkansas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2017
Product Description About Product Description
Full technical description of the product.
VANC 50MCG/ML-HEP 100U/ML in 2ML, Packed in 2 mL Units, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Batch or Lot Expiration Information

Lot# Compounded on 05/27/2015, Discard After: 06/11/2015