🍔 Food 💊 Drugs 🏥 Medical Devices
Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7916-06, UPC 3 0043-0479-16 3. Also packaged under foreign label: NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Apple Cinnamon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05205 2. Class II

Reason: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health 20130618 Terminated
Distributed: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
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Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95. Class III

Reason: Failed Stability Specifications: this product is below specification for preservative content.

Teva Pharmaceuticals USA, Inc. 20131114 Terminated
Distributed: Nationwide
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sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distributed by: Greenstone LLC, Peapack, NJ 07977 -- MADE IN INDIA --- NDC 59762-4960-1 Class II

Reason: Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life

Greenstone LLC 20131105 Terminated
Distributed: Nationwide and Puerto Rico
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Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061. NDC 14789-500-10. Class II

Reason: Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.

Fresenius Kabi USA, LLC 20131031 Terminated
Distributed: US: Nationwide
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Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. Class II

Reason: Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.

Hospira Inc. 20131212 Terminated
Distributed: Nationwide
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HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10. Class II

Reason: Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

KVK-Tech, Inc. 20131211 Terminated
Distributed: Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
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HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-011-01, 500 count NDC: 10702-011-50, 1000 count NDC: 10702-011-10. Class II

Reason: Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

KVK-Tech, Inc. 20131211 Terminated
Distributed: Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
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HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01. Class II

Reason: Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

KVK-Tech, Inc. 20131211 Terminated
Distributed: Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
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SELENIUM, Tablet, 50 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904316260. Class II

Reason: Labeling: Label Mixup :SELENIUM, Tablet, 50 mcg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD56917_13, EXP: 5/21/2014.

Aidapak Services, LLC 20130702 Terminated
Distributed: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
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NIACIN, Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904227260. Class II

Reason: Labeling: Label Mixup: NIACIN, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD54516_1, EXP: 5/20/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: W002920, EXP: 6/10/2014.

Aidapak Services, LLC 20130702 Terminated
Distributed: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
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