FDA Drug Recalls

1,709 recalls · Class III, newest first

Class III · Low risk Terminated Jun 21, 2013

FOLLOW YOUR DREAMS! Justice, Chocolate anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054…

Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Tween Brands Inc D-352-2014

Class III · Low risk Terminated Jun 21, 2013

Girls can change the World, Green Apple Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, Distr by Tween Brands New Albany, OH…

Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Tween Brands Inc D-351-2014

Class III · Low risk Terminated Jun 21, 2013

Shine from within blueberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto…

Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Tween Brands Inc D-350-2014

Class III · Low risk Terminated Jun 21, 2013

Share a Smile Mixed berry Anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto…

Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Tween Brands Inc D-349-2014

Class III · Low risk Terminated Jun 21, 2013

Believe in Yourself Strawberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz., Distr by Tween Brands New Albany, OH 43054…

Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Tween Brands Inc D-348-2014

Class III · Low risk Terminated Jun 18, 2013

Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx…

Reason Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This…

Teva Pharmaceuticals USA, Inc. NDC 0093-4160-78 D-803-2013

Class III · Low risk Terminated Jun 14, 2013

Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton…

Reason Labeling: Missing Label; missing label on blister card

Boehringer Ingelheim Roxane Inc NDC 0054-0018-20 D-882-2013

Class III · Low risk Terminated Jun 13, 2013

Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as…

Reason Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.

Bayer HealthCare Pharmaceuticals Inc. D-807-2013

Class III · Low risk Terminated Jun 3, 2013

Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC…

Reason Failed Impurities/Degradation Specifications

Actavis NDC 0591-3212-54 D-599-2013

Class III · Low risk Terminated May 31, 2013

Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only…

Reason Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because…

Pfizer Inc. NDC 0046-0975-11 D-631-2013

Class III · Low risk Terminated May 31, 2013

Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only…

Reason Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots…

Pfizer Inc. NDC 0046-0875-11 D-630-2013

Class III · Low risk Terminated May 31, 2013

Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31)…

Reason Failed Dissolution Specification

Pfizer Inc NDC 0025-2742-31 D-607-2013

Class III · Low risk Terminated May 30, 2013

Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous…

Reason Presence of Particulate Matter; particulate found in retain samples

Pharmalucence, Inc. NDC 45567-0555-1 D-808-2013

Class III · Low risk Terminated May 28, 2013

Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First…

Reason Failed Stability Specifications: Unable to meet shelf life expiry.

Faria Limited LLC dba Sheffield Pharmaceuticals D-604-2013

Class III · Low risk Terminated May 21, 2013