🍔 Food 💊 Drugs 🏥 Medical Devices
Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3 Class II

Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Apotex Inc. 20140324 Terminated
Distributed: Nationwide and Puerto Rico
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PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5 Class II

Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Apotex Inc. 20140324 Terminated
Distributed: Nationwide and Puerto Rico
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Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3 Class II

Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Apotex Inc. 20140324 Terminated
Distributed: Nationwide and Puerto Rico
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Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013 Class II

Reason: Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.

Sage Products Inc 20140827 Terminated
Distributed: Nationwide
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OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21 Class II

Reason: Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.

Qualitest Pharmaceuticals 20140827 Terminated
Distributed: Nationwide
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Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78. Class I

Reason: Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Pharmakon Pharmaceuticals 20140421 Terminated
Distributed: United States: TX, IL, MD, IN
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Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70. Class II

Reason: Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Pharmakon Pharmaceuticals 20140421 Terminated
Distributed: United States: TX, IL, MD, IN
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Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48. Class I

Reason: Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Pharmakon Pharmaceuticals 20140421 Terminated
Distributed: United States: TX, IL, MD, IN
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Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68. Class I

Reason: Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Pharmakon Pharmaceuticals 20140421 Terminated
Distributed: United States: TX, IL, MD, IN
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All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX Class II

Reason: Lack of Assurance of Sterility

Abrams Royal Pharamacy 20131219 Terminated
Distributed: Nationwide and to Canada
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