🍔 Food 💊 Drugs 🏥 Medical Devices
Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27 Class II

Reason: Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product

American Specialty Pharmacy 20141212 Terminated
Distributed: TX
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5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04 Class II

Reason: Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

Baxter Healthcare Corp. 20150318 Terminated
Distributed: Nationwide
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0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03 Class II

Reason: Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

Baxter Healthcare Corp. 20150318 Terminated
Distributed: Nationwide
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B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040. Class II

Reason: Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss

Bethel Nutritional Consulting, Inc 20141219 Terminated
Distributed: Nationwide
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AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road, Basking Ridge, NJ 07920. Available in A) E or 22 cu ft cylinder, NDC: 55037-302-09; B) 40 cu ft cylinder, NDC: 55037-302-10; C) 200 cu ft cylinder, NDC: 55037-302-15; D) 220 cu ft cylinder, NDC: 55037-302-16; E) 300 cu ft cylinder, NDC: 55037-302-18, 55037-302-19, 55037-302-20. Class III

Reason: Failed Impurities/Degradation Specification; out of specification results for carbon dioxide

Matheson, Inc. 20150310 Terminated
Distributed: Michigan and Wisconsin
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Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 Class II

Reason: Lack of Assurance of Sterility; due to leaking vials

Mylan Institutional LLC 20150218 Terminated
Distributed: Nationwide and Puerto Rico
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Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 Class II

Reason: Lack of Assurance of Sterility; due to leaking vials

Mylan Institutional LLC 20150218 Terminated
Distributed: Nationwide and Puerto Rico
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Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25. Class III

Reason: Failed Impurities/Degradation Specifications; 12 month stability testing.

West-Ward Pharmaceutical Corporation 20150216 Terminated
Distributed: Nationwide
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Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0073-02, UPC 3 11917 15114 4. Class II

Reason: Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.

Tarmac Products, Inc. 20150206 Terminated
Distributed: Nationwide
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5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. Class II

Reason: Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.

Hospira Inc. 20150305 Terminated
Distributed: Nationwide
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