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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 9221–9240 of 17,793 recalls

Class ITerminated

Gaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

June 20, 2018 · DrugView details →

Class ITerminated

Gaia Kratom (mitragyna speciosa) powder, Purple 8-1, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

June 20, 2018 · DrugView details →

Class ITerminated

Gaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical Red Borneo, 1oz, 250g, kg Gaia Ethnobotanical Red Dragon, 1oz, 250g, 1kg Gaia Ethnobotanical Red Horn, 1oz, 250g, 1kg Gaia Ethnobotanical Red Kapuas Hulu 1oz, 250g, 1kg Gaia Ethnobotanical Red MD, 1oz, 250g, 1kg Gaia Ethnobotanical Red Thai, 1oz, 250g,. 1kg Gaia Ethnobotanical Super Green Malay 1oz, 250g, 1kg Gaia Ethnobotanical White Borneo 1oz, 250g, 1kg Gaia Ethnobotanical White Horn, 1 oz, 250g, 1kg Gaia Ethnobotanical White MD, 1 oz, 250 g, 1 kg Gaia Ethnobotanical White Thai, 1oz, 250 g, 1 kg Gaia Ethnobotanical Yellow Thai, 1oz, 250 g, 1kg Gaia Ethnobotanical Yellow Vietnam 1oz, 250g, 1kg

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

June 20, 2018 · DrugView details →

Class ITerminated

Gaia Kratom (mitragyna speciosa) powder, Plantation Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

June 20, 2018 · DrugView details →

Class IITerminated

fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.

Advanced Pharma Inc.

Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.

June 20, 2018 · DrugView details →

Class ITerminated

Gaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

June 20, 2018 · DrugView details →

Class IIITerminated

Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.

Wockhardt Limited

Failed Impurities/Degradation Specifications

June 19, 2018 · DrugView details →

Class IIITerminated

Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.

Wockhardt Limited

Failed Impurities/Degradation Specifications

June 19, 2018 · DrugView details →

Class IIITerminated

Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15

Validus Pharmaceuticals, Inc.

Subpotency: lower than expected potency result was obtained at the 18 month stability time point.

June 15, 2018 · DrugView details →

Class IIITerminated

Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59

Validus Pharmaceuticals, Inc.

Subpotency: lower than expected potency result was obtained at the 18 month stability time point.

June 15, 2018 · DrugView details →

Class IITerminated

Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

June 14, 2018 · DrugView details →

Class IITerminated

Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

June 14, 2018 · DrugView details →

Class IITerminated

Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

June 14, 2018 · DrugView details →

Class IITerminated

Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

June 14, 2018 · DrugView details →

Class IITerminated

Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

June 14, 2018 · DrugView details →

Class IITerminated

Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

June 14, 2018 · DrugView details →

Class IITerminated

Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

June 14, 2018 · DrugView details →

Class IITerminated

Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

June 14, 2018 · DrugView details →

Class IITerminated

Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

June 14, 2018 · DrugView details →

Class IITerminated

Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

June 14, 2018 · DrugView details →

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