🍔 Food 💊 Drugs 🏥 Medical Devices
0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Class I

Reason: Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Baxter Healthcare Corp. 20131121 Terminated
Distributed: Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
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5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38. Class I

Reason: Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Baxter Healthcare Corp. 20131121 Terminated
Distributed: Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
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Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30. Class I

Reason: Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.

Hospira Inc. 20131018 Terminated
Distributed: Nationwide
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Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04. Class I

Reason: Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.

Baxter Healthcare Corp. 20131118 Terminated
Distributed: US Nationwide
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Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-1115-04. Class I

Reason: Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.

Baxter Healthcare Corp. 20131118 Terminated
Distributed: US Nationwide
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Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04. Class I

Reason: Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.

Baxter Healthcare Corp. 20131118 Terminated
Distributed: US Nationwide
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Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle Biologics, Inc. Bannockburn, IL 60015. NDC:76128-155-75 Class III

Reason: Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.

Pinnacle Biologics Inc 20140210 Terminated
Distributed: US: Nationwide and Taiwan
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Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 Class I

Reason: Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.

Specialty Medicine Compounding Pharmacy, P.C. 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
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Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20 Class III

Reason: Failed Impurity/degradation Specification

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 20140128 Terminated
Distributed: US: Nationwide
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BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bottle, Distributed by CTV Best Group Inc., P.O. Box 956452, Duluth, GA 30095. Class I

Reason: Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making it an unapproved new drug.

CTV Best Group 20130801 Terminated
Distributed: Nationwide and Australia, Canada.
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