FDA Recall
Terminated
Historical recordClass III
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.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
- Published
- April 9, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
by American Health Packaging
- Reason
- Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
- Published
- April 9, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01
by American Health Packaging
- Reason
- Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
- Published
- April 9, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
- Published
- April 9, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
- Published
- April 9, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by Viiv Healthcare Company
- Reason
- Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
- Published
- April 9, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Teva Pharmaceuticals USA
- 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.
- Published
- April 9, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Duloxetine 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
by Teva Pharmaceuticals USA
- 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.
- Published
- April 9, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Duloxetine 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
by Teva Pharmaceuticals USA
- 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.
- Published
- April 9, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20
by Hill Dermaceuticals, Inc.
- Reason
- Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Published
- April 2, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
SETON 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
by Hill Dermaceuticals, Inc.
- Reason
- Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Published
- April 2, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
SETON 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
by Hill Dermaceuticals, Inc.
- Reason
- Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Published
- April 2, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20
by Hill Dermaceuticals, Inc.
- Reason
- Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Published
- April 2, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ROYAL 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
by Hill Dermaceuticals, Inc.
- Reason
- Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Published
- April 2, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ROYAL 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
by Hill Dermaceuticals, Inc.
- Reason
- Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Published
- April 2, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Derma-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
by Hill Dermaceuticals, Inc.
- Reason
- Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Published
- April 2, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Derma-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
by Hill Dermaceuticals, Inc.
- Reason
- Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Published
- April 2, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
DermOtic 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
by Hill Dermaceuticals, Inc.
- Reason
- Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Published
- April 2, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (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.
by Noven Pharmaceuticals, Inc.
- Reason
- 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.
- Published
- March 26, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (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.
by Noven Pharmaceuticals, Inc.
- Reason
- 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.
- Published
- March 26, 2014
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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