🍔 Food 💊 Drugs 🏥 Medical Devices
Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110. Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. 100 Tablet Bottle NDC: 51672-4028-1, 1000 Tablet Bottle NDC: 51672-4028-3. Class III

Reason: Failed Content Uniformity Specifications.

Taro Pharmaceuticals U.S.A., Inc. 20140825 Terminated
Distributed: United States including: OH, HI, NH, MS, IL, TX, CA.
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Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9 Class III

Reason: Failed Impurity/Degradation Specification; high out of specification for CAD II degradant

Apotex Corp. 20140821 Terminated
Distributed: Nationwide
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0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03 Class II

Reason: Lack of Assurance of Sterility; complaints of mold in the overpouch

Baxter Healthcare Corp. 20140730 Terminated
Distributed: Nationwide
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CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005. Class III

Reason: Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.

ChiroNutraceutical LLC 20140820 Terminated
Distributed: U.S. Nationwide
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PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3666-3 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) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3664-3 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) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3663-3 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 CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3670-3 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 CR (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 60505-3669-3 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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Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3 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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