🍔 Food 💊 Drugs 🏥 Medical Devices
Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2303-1. Class II

Reason: Penicillin Cross Contamination

Terra-Medica Inc. 20140303 Terminated
Distributed: Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2304-1. Class II

Reason: Penicillin Cross Contamination

Terra-Medica Inc. 20140303 Terminated
Distributed: Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2305-1. Class II

Reason: Penicillin Cross Contamination

Terra-Medica Inc. 20140303 Terminated
Distributed: Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324. Class III

Reason: Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point

Teva Pharmaceuticals USA 20140211 Terminated
Distributed: Nationwide
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HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01 Class II

Reason: Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

American Health Packaging 20140131 Terminated
Distributed: Nationwide
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HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01 Class II

Reason: Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

American Health Packaging 20140131 Terminated
Distributed: Nationwide
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Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-03. Class III

Reason: Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.

Lupin Pharmaceuticals Inc. 20140127 Terminated
Distributed: Nationwide
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Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02. Class III

Reason: Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.

Lupin Pharmaceuticals Inc. 20140127 Terminated
Distributed: Nationwide
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Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13 Class III

Reason: Cross Contamination with Other Products: Product contains Promacta (eltrombopag).

Viiv Healthcare Company 20140211 Terminated
Distributed: Nationwide including Puerto Rico
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Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7544-56 Class II

Reason: Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.

Teva Pharmaceuticals USA 20140304 Terminated
Distributed: Nationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.
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