🍔 Food 💊 Drugs 🏥 Medical Devices
Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045. Class II

Reason: Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot

Hospira, Inc. 20130520 Terminated
Distributed: Nationwide
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TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135-0181-02 Class III

Reason: Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets

GlaxoSmithKline, LLC. 20130718 Terminated
Distributed: U.S. Nationwide
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Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01 Class II

Reason: Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Teva Pharmaceuticals USA, Inc. 20130618 Terminated
Distributed: Nationwide
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Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01 Class II

Reason: Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Teva Pharmaceuticals USA, Inc. 20130618 Terminated
Distributed: Nationwide
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Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01 Class II

Reason: Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Teva Pharmaceuticals USA, Inc. 20130618 Terminated
Distributed: Nationwide
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Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign packaging do not have NDC number This product was only distributed to Novartis Brazil by the recalling firm Class II

Reason: Defective container: products are packaged in pouches which may not have been fully sealed

Novartis Consumer Health 20130606 Terminated
Distributed: Nationwide, Puerto Rico, Brazil and Panama
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No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02 Class II

Reason: Defective container: products are packaged in pouches which may not have been fully sealed

Novartis Consumer Health 20130606 Terminated
Distributed: Nationwide, Puerto Rico, Brazil and Panama
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Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches. The foreign packaging do not have NDC numbers Class II

Reason: Defective container: products are packaged in pouches which may not have been fully sealed

Novartis Consumer Health 20130606 Terminated
Distributed: Nationwide, Puerto Rico, Brazil and Panama
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Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin, 65 mg Caffeine), boxes of 48/4-ct pouches Foreign packaging do not have NDC numbers. Class II

Reason: Defective container: products are packaged in pouches which may not have been fully sealed

Novartis Consumer Health 20130606 Terminated
Distributed: Nationwide, Puerto Rico, Brazil and Panama
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Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01 Class II

Reason: Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules

Teva Pharmaceuticals USA, Inc. 20130723 Terminated
Distributed: Nationwide and Puerto Rico
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