US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated

Phenylephrine HCl

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 88888-5230-12 D-0263-2015
Class II · Moderate risk Terminated

Leuprolide 50 mcg/0.1 mL Micro Lupron Kit

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 88888-1124-57 D-0262-2015
Class II · Moderate risk Terminated

Tri-Mix

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 88888-5123-09 D-0261-2015
Class II · Moderate risk Terminated

Methyl B12 25 mg/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 88888-2014-37 D-0260-2015
Class II · Moderate risk Terminated

Testosterone CYP-250/PROP-20 mg

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 88888-0326-44 D-0259-2015
Class II · Moderate risk Terminated

Meropenem I.V. 1 g is supplied in 30 mL injection vials

Reason Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.

Hospira Inc. NDC 0409-3506-01 D-0303-2015
Class II · Moderate risk Terminated

Mercaptopurine Tablets

Reason Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Prometheus Laboratories Inc. NDC 49884-922-02 D-0249-2015
Class II · Moderate risk Terminated

Gabapentin Capsules

Reason Failed Tablet/Capsule Specifications: Complaints of empty capsules received.

Aurobindo Pharma USA Inc NDC 16714-662-01 D-0330-2015
Class II · Moderate risk Terminated

Obagi Nu-Derm Clear

Reason Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte.

Obagi Medical Products NDC 62032-101-36 D-0234-2015
Class II · Moderate risk Terminated

Cyproheptadine HCl Syrup

Reason Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.

Pharmaceutical Associates Inc NDC 0121-4788-10 D-0240-2015
Class II · Moderate risk Terminated

Tri-mix #4

Reason Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Vann Healthcare Services Inc D-0312-2015
Class II · Moderate risk Terminated

Lidocaine 4% Syr

Reason Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Vann Healthcare Services Inc D-0311-2015
Class II · Moderate risk Terminated

Epinephrine 1:1000

Reason Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Vann Healthcare Services Inc D-0310-2015
Class II · Moderate risk Terminated

Hydroxyprogesterone Caproate

Reason Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Vann Healthcare Services Inc D-0309-2015
Class II · Moderate risk Terminated

Sterile Water for Injection

Reason Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Hospira Inc. NDC 0409-7990-09 D-0287-2015
Class II · Moderate risk Terminated

0.45% Sodium Chloride Injection

Reason Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Hospira Inc. NDC 0409-7985-09 D-0286-2015
Class II · Moderate risk Terminated

0.9% Sodium Chloride Injection

Reason Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Hospira Inc. NDC 0409-7983-09 D-0285-2015
Class II · Moderate risk Terminated

Normosol-R Multiple Electrolytes Injection Type 1

Reason Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Hospira Inc. NDC 0409-7967-09 D-0284-2015
Class II · Moderate risk Terminated

Lactated Ringer's Injection

Reason Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Hospira Inc. NDC 0409-7953-09 D-0283-2015
Class II · Moderate risk Terminated

5% Dextrose and 0.9% Sodium Chloride Injection

Reason Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Hospira Inc. NDC 0409-7941-09 D-0282-2015
Class II · Moderate risk Terminated

Lactated Ringer's and 5% Dextrose Injection

Reason Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Hospira Inc. NDC 0409-7929-09 D-0281-2015
Class II · Moderate risk Terminated

5% Dextrose and 0.45% Sodium Chloride Injection

Reason Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Hospira Inc. NDC 0409-7926-09 D-0280-2015
Class II · Moderate risk Terminated

5% Dextrose Injection

Reason Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Hospira Inc. NDC 0409-7922-09 D-0279-2015