🍔 Food 💊 Drugs 🏥 Medical Devices
Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61 Class II

Reason: Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets

Legacy Pharmaceutical Packaging 20140409 Terminated
Distributed: IN
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Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69. Class I

Reason: Superpotent Drug: Product contains twice the stated amount of midazolam.

Pharmakon Pharmaceuticals 20140326 Terminated
Distributed: IN
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Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9. Class I

Reason: Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot

Greenstone Llc 20140306 Terminated
Distributed: Nationwide and Puerto Rico
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CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15. Class II

Reason: Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.

Carefusion 2200 Inc 20131220 Terminated
Distributed: Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines
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CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18 Class II

Reason: Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.

Carefusion 2200 Inc 20131220 Terminated
Distributed: Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines
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Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10. Class I

Reason: Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.

Hospira Inc. 20140421 Terminated
Distributed: Nationwide.
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LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30 Class II

Reason: Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning

Golden State Medical Supply Inc. 20140414 Terminated
Distributed: Nationwide
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GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1 Class II

Reason: Defective Container: Tamper evident ring failures discovered on some bottles.

Pfizer Inc. 20140129 Terminated
Distributed: Nationwide, Italy and Republic of South Korea
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Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02. Class II

Reason: Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.

Wockhardt Usa Inc. 20140410 Terminated
Distributed: Nationwide.
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ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY Class II

Reason: Non-sterility: due to a failed sterility test

Teva Pharmaceuticals USA 20140321 Terminated
Distributed: NY and KY
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