US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated

Acetylsalicyclic acid active pharmaceutical ingredient packaged…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-500-2015
Class II · Moderate risk Terminated

Acetazolamide active pharmaceutical ingredient packaged in…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-499-2015
Class II · Moderate risk Terminated

2-Methoxyestradiol active pharmaceutical ingredient packaged in…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-498-2015
Class II · Moderate risk Terminated

5-Fluorouracil active pharmaceutical ingredient packaged in…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-497-2015
Class II · Moderate risk Terminated

2,3-Dimercaptosuccinic Acid

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-496-2015
Class II · Moderate risk Terminated

2,3-Dimercaptopropanesulfonic Acid Sodium Salt

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-495-2015
Class II · Moderate risk Terminated

3,4-Diaminopyridine active pharmaceutical ingredient packaged in…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-494-2015
Class II · Moderate risk Terminated

2-Deoxy-D-Glucose active pharmaceutical ingredient packaged in…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-493-2015
Class II · Moderate risk Terminated

4-Aminopyridine active pharmaceutical ingredient packaged in…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-492-2015
Class II · Moderate risk Terminated

5-Aminolevulinic Acid Hydrochloride active pharmaceutical…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-491-2015
Class II · Moderate risk Terminated

MAYHEM capsules

Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.

Chaotic Labz D-0314-2015
Class II · Moderate risk Terminated

Gentamicin Injection

Reason Defective Container: Vials may be missing stoppers.

Fresenius Kabi USA, LLC NDC 63323-010-20 D-0290-2015
Class II · Moderate risk Terminated

Potassium Chloride Injection

Reason Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.

Baxter Healthcare Corp. NDC 0338-0709-48 D-0256-2015
Class II · Moderate risk Terminated

Sodium Tetradecyl SO4 0.3% Inj.

Reason Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Perry Drug Inc. NDC 88888-6427-90 D-0275-2015
Class II · Moderate risk Terminated

Hcg - 10

Reason Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Perry Drug Inc. NDC 88888-0216-49 D-0274-2015
Class II · Moderate risk Terminated

Tri Mix PF SYR 0.5 mL Inj.

Reason Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Perry Drug Inc. NDC 88888-5036-49 D-0273-2015
Class II · Moderate risk Terminated

Hcg-20

Reason Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Perry Drug Inc. NDC 88888-2195-47 D-0272-2015
Class II · Moderate risk Terminated

Cyclosporine 0.045 % Sol PF

Reason Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Perry Drug Inc. NDC 88888-5120-67 D-0271-2015
Class II · Moderate risk Terminated

2Ml HCG 10

Reason Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Perry Drug Inc. NDC 88888-7945-17 D-0270-2015
Class II · Moderate risk Terminated

Hcg 10

Reason Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Perry Drug Inc. NDC 88888-5012-34 D-0269-2015
Class II · Moderate risk Terminated

HCG 200 IU/mL Injection

Reason Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Perry Drug Inc. NDC 88888-7745-68 D-0268-2015
Class II · Moderate risk Terminated

HCG Low Dose 10 IU / 0.1 mL

Reason Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Perry Drug Inc. NDC 88888-2596-17 D-0267-2015
Class II · Moderate risk Terminated

Tri-mix Antidote 10 each Syringes

Reason Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Perry Drug Inc. NDC 88888-0205-17 D-0266-2015
Class II · Moderate risk Terminated

HCG Low Dose 30 IU/0.1 mL

Reason Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Perry Drug Inc. NDC 88888-0231-54 D-0265-2015
Class II · Moderate risk Terminated

Testosterone Cyp 200 mg/mL Sesame Inj.

Reason Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Perry Drug Inc. NDC 88888-7906-71 D-0264-2015