🍔 Food 💊 Drugs 🏥 Medical Devices
Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02 Class II

Reason: CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.

Teva Pharmaceuticals USA 20140124 Terminated
Distributed: Nationwide.
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Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02. Class II

Reason: CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.

Teva Pharmaceuticals USA 20140124 Terminated
Distributed: Nationwide.
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Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2. Class II

Reason: Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.

Actavis Elizabeth LLC 20140204 Terminated
Distributed: Nationwide
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Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only. Manufactured for: Bristol-Myers Squibb & Gilead Sciences, LLC, Foster City, CA 94404. Made in Ireland. NDC 15584-0101-1. Manufactured for: Bristol-Myers-Squibb & Gilead Sciences, LLC, Foster City, CA 94404 Made in Ireland Class III

Reason: Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.

Gilead Sciences, Inc. 20140219 Terminated
Distributed: Nationwide including Puerto Rico.
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Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02 Class II

Reason: Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER

Caraco Pharmaceutical Laboratories, Ltd. 20140128 Terminated
Distributed: Nationwide
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Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77. Class III

Reason: Subpotent Drug: Drug potency was compromised during shipment.

Actavis 20140207 Terminated
Distributed: Distributed nationwide to physicians as samples. No military/ govt/ VA or foreign consignees.
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Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton) Class II

Reason: Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.

Actavis Elizabeth LLC 20131106 Terminated
Distributed: Nationwide
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Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90 Class II

Reason: Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.

Ranbaxy Inc. 20140116 Terminated
Distributed: Nationwide
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Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose Delivery System containing 2 mL Sterile Water for Injection, USP per carton (NDC 52544-188-76), 11.25 mg, Rx Only, Dist. By: Watson Pharma, Inc., Morristown, NJ 07962, Mfd. by: Debio RP, CH-1920 Martigny, Switzerland. Class II

Reason: Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.

Actavis Inc 20131209 Terminated
Distributed: Nationwide and Puerto Rico
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Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01 Class II

Reason: Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.

Mylan Pharmaceuticals Inc. 20140114 Terminated
Distributed: Nationwide.
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