Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2014-04-16FDA-DrugTerra-Medica Inc.Class IIPleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral 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: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL Cartons, Oral 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: 49807-2308-2 .
Penicillin Cross Contamination
- 2014-04-16FDA-DrugTerra-Medica Inc.Class IIPleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral 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: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 50 x 1mL Cartons, Oral 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: 49807-2306-2.
Penicillin Cross Contamination
- 2014-04-16FDA-DrugTerra-Medica Inc.Class IIPleo Not DROPS, 5X, 10 mL Bottles, Oral 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: 49807-2301-1.
Penicillin Cross Contamination
- 2014-04-16FDA-DrugTerra-Medica Inc.Class IIPleo Not TABLETS 5X, 20 Tablet Cartons, Oral 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: 49807-2302-1.
Penicillin Cross Contamination
- 2014-04-16FDA-DrugTerra-Medica Inc.Class IIPleo 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.
Penicillin Cross Contamination
- 2014-04-16FDA-DrugTerra-Medica Inc.Class IIPleo 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.
Penicillin Cross Contamination
- 2014-04-16FDA-DrugTerra-Medica Inc.Class IIPleo 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.
Penicillin Cross Contamination
- 2014-04-09FDA-DrugTeva Pharmaceuticals USAClass IIIQVAR¿ (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.
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
- 2014-04-09FDA-DrugAmerican Health PackagingClass IIHydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
- 2014-04-09FDA-DrugAmerican Health PackagingClass IIHydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
- 2014-04-09FDA-DrugLupin Pharmaceuticals Inc.Class IIISuprax, 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.
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
- 2014-04-09FDA-DrugLupin Pharmaceuticals Inc.Class IIISuprax, 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.
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
- 2014-04-09FDA-DrugViiv Healthcare CompanyClass IIITivicay (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
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
- 2014-04-09FDA-DrugTeva Pharmaceuticals USAClass IIDuloxetine 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
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.
- 2014-04-09FDA-DrugTeva Pharmaceuticals USAClass IIDuloxetine Delayed-Release Capsules, USP, 30 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 0093-7543-56
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.
- 2014-04-09FDA-DrugTeva Pharmaceuticals USAClass IIDuloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06
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.
- 2014-04-02FDA-DrugHill Dermaceuticals, Inc.Class IIISETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- 2014-04-02FDA-DrugHill Dermaceuticals, Inc.Class IIISETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- 2014-04-02FDA-DrugHill Dermaceuticals, Inc.Class IIISETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- 2014-04-02FDA-DrugHill Dermaceuticals, Inc.Class IIIROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- 2014-04-02FDA-DrugHill Dermaceuticals, Inc.Class IIIROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- 2014-04-02FDA-DrugHill Dermaceuticals, Inc.Class IIIROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- 2014-04-02FDA-DrugHill Dermaceuticals, Inc.Class IIIDerma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- 2014-04-02FDA-DrugHill Dermaceuticals, Inc.Class IIIDerma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- 2014-04-02FDA-DrugHill Dermaceuticals, Inc.Class IIIDermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- 2014-03-26FDA-DrugNoven Pharmaceuticals, Inc.Class IIDaytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patches per box, Rx Only.Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5555-3.
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
- 2014-03-26FDA-DrugNoven Pharmaceuticals, Inc.Class IIDaytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3.
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
- 2014-03-26FDA-DrugFabscout Entertainment, IncClass ISilver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language)
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
- 2014-03-26FDA-DrugFabscout Entertainment, IncClass IClalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
- 2014-03-26FDA-DrugPaddock Laboratories, LLCClass IIPerrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01
Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml.
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