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 →
FDA Recall
Terminated
Historical recordClass I
Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language)
by Fabscout Entertainment, Inc
- Reason
- 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.
- Published
- March 26, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
by Fabscout Entertainment, Inc
- Reason
- 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.
- Published
- March 26, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01
by Paddock Laboratories, LLC
- Reason
- Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml.
- Published
- March 26, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10
by Mckesson Packaging Services
- Reason
- Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
- Published
- March 26, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43
by Pfizer Us Pharmaceutical Group
- Reason
- Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
- Published
- March 26, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001
by Traxx International Corp
- Reason
- Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.
- Published
- March 26, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
by Baxter Healthcare Corp.
- Reason
- Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
- Published
- March 26, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.
by Baxter Healthcare Corp.
- Reason
- Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
- 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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