FDA Recall
TerminatedTerminated: December 28, 2015Historical recordClass II
0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 28, 2015Historical recordClass II
0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 28, 2015Historical recordClass II
Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7967-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 28, 2015Historical recordClass II
Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 28, 2015Historical recordClass II
5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7941-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 28, 2015Historical recordClass II
Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7929-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 28, 2015Historical recordClass II
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 28, 2015Historical recordClass II
5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 28, 2015Historical recordClass II
Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 28, 2015Historical recordClass II
Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7670-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015 by Baxter Healthcare Corporation 250 Road 144 Jayuya, Puerto Rico, 00664, NDC 0338-0431-03
by Baxter Healthcare Corp.
- Reason
- Subpotent Drug: Heparin raw material was found to have low potency
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 3, 2015Historical recordClass II
Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-6427-90
by Perry Drug Inc.
- Reason
- Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Published
- December 3, 2014
- Distribution
- Kansas and Missouri
View recall →
FDA Recall
TerminatedTerminated: November 3, 2015Historical recordClass II
HCG - 10,000 Unit PF Inject, 1mL Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS NDC 88888-0216-49
by Perry Drug Inc.
- Reason
- Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Published
- December 3, 2014
- Distribution
- Kansas and Missouri
View recall →
FDA Recall
TerminatedTerminated: November 3, 2015Historical recordClass II
Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5036-49
by Perry Drug Inc.
- Reason
- Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Published
- December 3, 2014
- Distribution
- Kansas and Missouri
View recall →
FDA Recall
TerminatedTerminated: November 3, 2015Historical recordClass II
HCG-20,000 U/2 mL Vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2195-47
by Perry Drug Inc.
- Reason
- Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Published
- December 3, 2014
- Distribution
- Kansas and Missouri
View recall →
FDA Recall
TerminatedTerminated: November 3, 2015Historical recordClass II
Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5120-67
by Perry Drug Inc.
- Reason
- Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Published
- December 3, 2014
- Distribution
- Kansas and Missouri
View recall →
FDA Recall
TerminatedTerminated: November 3, 2015Historical recordClass II
2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17
by Perry Drug Inc.
- Reason
- Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Published
- December 3, 2014
- Distribution
- Kansas and Missouri
View recall →
FDA Recall
TerminatedTerminated: November 3, 2015Historical recordClass II
HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34
by Perry Drug Inc.
- Reason
- Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Published
- December 3, 2014
- Distribution
- Kansas and Missouri
View recall →
FDA Recall
TerminatedTerminated: November 3, 2015Historical recordClass II
HCG 200 IU/mL Injection, 30Ml, 10 mL vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7745-68
by Perry Drug Inc.
- Reason
- Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Published
- December 3, 2014
- Distribution
- Kansas and Missouri
View recall →
FDA Recall
TerminatedTerminated: November 3, 2015Historical recordClass II
HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17
by Perry Drug Inc.
- Reason
- Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Published
- December 3, 2014
- Distribution
- Kansas and Missouri
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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