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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 10741–10760 of 17,793 recalls

Class IIITerminated

Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-03

Pharmedium Services Llc

Labeling: Incorrect or Missing Lot and/or Exp Date

February 15, 2017 · DrugView details →

Class IIITerminated

Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 600 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-279-33

Pharmedium Services Llc

Labeling: Incorrect or Missing Lot and/or Exp Date

February 15, 2017 · DrugView details →

Class IIITerminated

Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-25

Pharmedium Services Llc

Labeling: Incorrect or Missing Lot and/or Exp Date

February 15, 2017 · DrugView details →

Class IIITerminated

Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 270 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-044-57

Pharmedium Services Llc

Labeling: Incorrect or Missing Lot and/or Exp Date

February 15, 2017 · DrugView details →

Class IIITerminated

Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India,NDC 55111-137-81

Dr. Reddy's Laboratories, Inc.

Failed dissolution specifications - low dissolution results at S3 stage.

February 15, 2017 · DrugView details →

Class IIITerminated

Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-023-09

Pharmedium Services Llc

Labeling: Incorrect or Missing Lot and/or Exp Date

February 15, 2017 · DrugView details →

Class IIITerminated

Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chloride Injection, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-100-13

Pharmedium Services Llc

Labeling: Incorrect or Missing Lot and/or Exp Date

February 15, 2017 · DrugView details →

Class IITerminated

Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13

AVKARE Inc.

Failed impurities/ degradation specifications: Product was above specification for unknown impurities.

February 15, 2017 · DrugView details →

Class IIITerminated

Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81

Dr. Reddy's Laboratories, Inc.

Failed dissolution specifications - low dissolution results at S3 stage.

February 15, 2017 · DrugView details →

Class IIITerminated

Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, NDC 45802-806-01, UPC 3 45802-806-01 7.

L. Perrigo Company

Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.

February 13, 2017 · DrugView details →

Class IIITerminated

Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Allegan, MI 49010, NDC 45802-237-01, UPC 3 45802-237-01 9.

L. Perrigo Company

Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.

February 13, 2017 · DrugView details →

Class IIITerminated

PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL), Colgate Oral Pharmaceuticals, Inc., New York, NY 10022 --- NDC 0126-0016-61, UPC 3834110622

Colgate Palmolive Co

Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.

February 13, 2017 · DrugView details →

Class IITerminated

REVERSE DML LOTION (Ketoconazole 2%, Metronidazole 2%, sulfacetamide sodium 10%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

February 10, 2017 · DrugView details →

Class IITerminated

LP CREAM (Lidocaine 15%/Prilocaine 5%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

February 10, 2017 · DrugView details →

Class IITerminated

CUSTOM LIGHTENING/BRIGHTENING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

February 10, 2017 · DrugView details →

Class IITerminated

TRI-BLEACHING CREAM (Retinoic Acid 0.1%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

February 10, 2017 · DrugView details →

Class IITerminated

HYDROCORTISONE 2.5% WITH ALOE VERA CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

February 10, 2017 · DrugView details →

Class IITerminated

CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% OINTMENT, CLOBETASOL 0.05%/ SODIUM, SULFACETAMIDE 10% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

February 10, 2017 · DrugView details →

Class IITerminated

INTIMATE BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

February 10, 2017 · DrugView details →

Class IITerminated

HYDROQUINONE 28% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

February 10, 2017 · DrugView details →

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