October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes, Rx only, Colonia Care Phar
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A,
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colo
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., S
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colo
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, C
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Co
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J.
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave.
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care Pharmacy, 515 Inman A
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J.
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia,
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia,
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia,
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 9, 2019DrugsFDA
Colonia Care Pharmacy recalls C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 51
Hazard: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
October 2, 2019DrugsFDA
Johnson Matthey Inc. recalls Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford,
Hazard: cGMP Deviations: Potential glass contamination
October 2, 2019DrugsFDA
Johnson Matthey Inc. recalls Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ
Hazard: cGMP Deviations: Potential glass contamination
October 2, 2019DrugsFDA
Johnson Matthey Inc. recalls Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptf
Hazard: cGMP Deviations: Potential glass contamination
October 2, 2019DrugsFDA
Akorn, Inc. recalls Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 6004
Hazard: cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
October 2, 2019DrugsFDA
Preferred Pharmaceuticals, Inc recalls Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anahe
Hazard: Failed Impurities/Degradation Specifications
October 2, 2019DrugsFDA
Cardinal Health dba Specialty Pharmaceutical Services recalls Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactur
Hazard: Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
October 2, 2019DrugsFDA
Darmerica, LLC recalls Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55
Hazard: Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
October 2, 2019DrugsFDA
EPI Health, LLC recalls minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only,
Hazard: Failed Dissolution Specifications:
October 2, 2019DrugsFDA
Shire Human Genetic Therapies, Inc. recalls Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only,
Hazard: Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
October 2, 2019DrugsFDA
Shire Human Genetic Therapies, Inc. recalls Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, M
Hazard: Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
October 2, 2019DrugsFDA
Shire Human Genetic Therapies, Inc. recalls Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, M
Hazard: Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
October 2, 2019DrugsFDA
Shire Human Genetic Therapies, Inc. recalls Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufac
Hazard: Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
October 2, 2019DrugsFDA
Pfizer Inc. recalls Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
October 2, 2019DrugsFDA
Pfizer Inc. recalls ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.