US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Class II · Moderate risk Terminated

Dexpanthenol 250mg/Ml

Reason Lack of Assurance of Sterility

RXQ Compounding LLC D-1645-2019
Class II · Moderate risk Terminated

Copper 0.4MG/ML

Reason Lack of Assurance of Sterility

RXQ Compounding LLC D-1643-2019
Class II · Moderate risk Terminated

Calcium Chloride 100mg/Ml

Reason Lack of Assurance of Sterility

RXQ Compounding LLC D-1641-2019
Class II · Moderate risk Terminated

Avastin

Reason Lack of Assurance of Sterility

RXQ Compounding LLC NDC 70731-0197-91 D-1637-2019
Class II · Moderate risk Terminated

Ascorbic Acid 500 MG/ML

Reason Crystallization

RXQ Compounding LLC D-1636-2019
Class II · Moderate risk Terminated

Ascorbic Acid 400 MG/ML

Reason Crystallization

RXQ Compounding LLC D-1635-2019
Class II · Moderate risk Terminated

Ascorbic Acid 500 MG/ML

Reason Crystallization

RXQ Compounding LLC D-1634-2019
Class II · Moderate risk Terminated

SUCCINYLcholine Chloride

Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Premier Pharmacy Labs Inc D-1428-2019
Class II · Moderate risk Terminated

SUCCINYLcholine Chloride

Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Premier Pharmacy Labs Inc D-1427-2019
Class II · Moderate risk Terminated

Sodium Bicarbonate INJ 8.4%

Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Premier Pharmacy Labs Inc D-1426-2019
Class II · Moderate risk Terminated

Riboflavin 5-Phosphate Sodium Ophthalmic Solution

Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Premier Pharmacy Labs Inc D-1425-2019
Class II · Moderate risk Terminated

Phenylephrine HCL PF INJ in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Premier Pharmacy Labs Inc D-1424-2019
Class II · Moderate risk Terminated

Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*

Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Premier Pharmacy Labs Inc D-1423-2019
Class II · Moderate risk Terminated

Neostigmine Methylsulfate

Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Premier Pharmacy Labs Inc D-1422-2019
Class II · Moderate risk Terminated

Naloxone HCL Preserved INJ

Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Premier Pharmacy Labs Inc D-1421-2019
Class II · Moderate risk Terminated

Mitomycin Preservative Free Irrigation

Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Premier Pharmacy Labs Inc D-1420-2019
Class II · Moderate risk Terminated

Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ

Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Premier Pharmacy Labs Inc D-1419-2019
Class II · Moderate risk Terminated

Isoproterenol HCL in D5W

Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Premier Pharmacy Labs Inc D-1418-2019