Multi-event December 2014 FDA Recall Drug by Walgreens Infusion Services

This Multi-event Class II drug recall was voluntarily initiated by Walgreens Infusion Services on December 26, 2014 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance.. The product was distributed in Texas, Florida, Virginia, Georgia, Louisiana, Mississippi and the recall is currently terminated.

Reported Recall Events

Recall Number: D-0375-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Total parenteral nutrition various strengths

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0344-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Cefoxitin various strength in normal saline bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0353-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Cefazolin various strengths in normal saline bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0350-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Cefuroxime various strengths in normal saline bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0356-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Daptomycin various strengths in normal saline bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0346-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Imipenem/ cilastatin various strength in normal saline bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0340-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Liposomal Amphotericin B 130 mg in dextrose bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0352-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Nafcillin various strengths in sterile water for injection bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0363-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Caspofungin various strengths in normal saline

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0341-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Amikacin various strength in normal saline bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0359-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Linezolid various strengths in dextrose

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0371-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Dehydrated alcohol vials

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0354-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Tobramycin various strengths in normal saline bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0362-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Milrinone various strengths in dextrose

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0361-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Acyclovir various strengths in normal saline

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0348-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Piperacillin/ tazobactam various strength in normal saline bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0366-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Folic acid 1 mg/ 0.2 ml pre-drawn syringes

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0364-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Dobutamine various strengths in dextrose

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0360-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Tigecycline various strengths in normal saline

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0369-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Magnesium sulfate various strengths in sodium chloride

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0355-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Gentamicin various strength in normal saline bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0342-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Aztreonam 1 gram in normal saline

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0367-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Thiamine 100 mg/ ml vials

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0365-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Dopamine various strengths in dextrose

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0345-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Ceftazidime various strength in normal saline bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0347-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Ertapenem various strength in normal saline bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0351-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Meropenem various strengths in normal saline bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0370-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Deferoxamine various strengths in normal saline

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0349-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Vancomycin various strengths in normal saline bags

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0372-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Diphenhydramine 50 mg/ml vials

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0357-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Ceftriaxone various strengths in normal saline

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0373-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Immune globulin g human various strengths

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0374-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
L-cysteine various strengths

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0368-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Ranitidine various strengths in syringes

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0358-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Levofloxacin various strengths in normal saline

Batch or Lot Expiration Information

Lot# All products within expiry.

Recall Number: D-0343-2015

Reason for Recall
Lack of sterility assurance.
Initiated
12-26-2014
Reported
01-28-2015
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Walgreens Infusion Services
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Cefepime various strengths in normal saline

Batch or Lot Expiration Information

Lot# All products within expiry.