FDA Recall
Terminated
Historical recordClass III
Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03
by Apotex Corp.
- Reason
- Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
- Published
- October 1, 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 mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
- Published
- October 1, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.
by Alvogen, Inc
- Reason
- Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.
- Published
- October 1, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.
by Baxter Healthcare Corp
- Reason
- Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
- Published
- October 1, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
by Qualitest Pharmaceuticals
- Reason
- Subpotent; 6 month stability time point
- Published
- October 1, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or Intravenous Use, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2012-32
by Hospira Inc.
- Reason
- Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
- Published
- October 1, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42
by Akorn, Inc.
- Reason
- Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
- Published
- October 1, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663
by Nova Products, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA; Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.
- Published
- September 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789
by Nova Products, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
- Published
- September 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orlando, FL 32789
by Nova Products, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZone 1200because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
- Published
- September 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA 90012
by Nova Products, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
- Published
- September 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City of Los Angeles, CA 90012
by Nova Products, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN PLATINUM because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
- Published
- September 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA 90012
by Nova Products, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN GOLD because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
- Published
- September 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineering Co., Ltd, USA.,
by Nova Products, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Black Ant because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.
- Published
- September 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.
by Nova Products, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.
- Published
- September 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vial Rx Only Distributed by Bristol Meyers Squibb Company, Princeton, NJ 08543 USA NDC 0590-0324-96
by Bristol-Meyers Squibb
- Reason
- Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials
- Published
- September 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA.
by Nature's Universe
- Reason
- Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
- Published
- September 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822.
by Baxter Healthcare Corp.
- Reason
- Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
- Published
- September 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043.
by Baxter Healthcare Corp.
- Reason
- Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
- Published
- September 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
by Baxter Healthcare Corp.
- Reason
- Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
- Published
- September 24, 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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