May 16, 2018DrugsFDA
Kroger Specialty Pharmacy, Inc. recalls Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57
Hazard: Lack of Processing Controls.
May 16, 2018DrugsFDA
Kroger Specialty Pharmacy, Inc. recalls Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98
Hazard: Lack of Processing Controls.
May 16, 2018DrugsFDA
Kroger Specialty Pharmacy, Inc. recalls Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01
Hazard: Lack of Processing Controls.
May 16, 2018DrugsFDA
Kroger Specialty Pharmacy, Inc. recalls Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30
Hazard: Lack of Processing Controls.
May 16, 2018DrugsFDA
Kroger Specialty Pharmacy, Inc. recalls Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Kit b.) 40 mg/0.8 mL (NDC 00074-4339-07) 28 d
Hazard: Lack of Processing Controls.
May 16, 2018DrugsFDA
Vitalab Pharmacy, Inc recalls Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papa
Hazard: Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
May 16, 2018DrugsFDA
Vitalab Pharmacy, Inc recalls Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Pros
Hazard: Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
May 16, 2018DrugsFDA
Vitalab Pharmacy, Inc recalls Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc
Hazard: Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
May 16, 2018DrugsFDA
Vitalab Pharmacy, Inc recalls Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
Hazard: Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
May 16, 2018DrugsFDA
Vitalab Pharmacy, Inc recalls Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Hazard: Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
May 16, 2018DrugsFDA
Vitalab Pharmacy, Inc recalls Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Hazard: Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
May 16, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's La
Hazard: Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
May 9, 2018DrugsFDA
Sanofi-Aventis U.S. LLC recalls Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC
Hazard: Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
May 9, 2018DrugsFDA
Rhodes Pharmaceuticals, L.P. recalls Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceu
Hazard: Failed Dissolution Specification: Low dissolution outside of specifications
May 9, 2018DrugsFDA
AuroMedics Pharma LLC recalls Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion,
Hazard: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
May 9, 2018DrugsFDA
AuroMedics Pharma LLC recalls Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion,
Hazard: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
May 9, 2018DrugsFDA
AuroMedics Pharma LLC recalls Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distrib
Hazard: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
May 9, 2018DrugsFDA
AuroMedics Pharma LLC recalls Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distribu
Hazard: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
May 9, 2018DrugsFDA
AuroMedics Pharma LLC recalls Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distribute
Hazard: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
May 9, 2018DrugsFDA
AuroMedics Pharma LLC recalls Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion,
Hazard: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
May 9, 2018DrugsFDA
AuroMedics Pharma LLC recalls Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Phar
Hazard: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
May 2, 2018DrugsFDA
Coastal Meds, LLC. recalls PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Hazard: Presence of Particulate matter. Recall due to presence of unknown particulate matter.
May 2, 2018DrugsFDA
Coastal Meds, LLC. recalls METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Hazard: Presence of Particulate matter. Recall due to presence of unknown particulate matter.
May 2, 2018DrugsFDA
Coastal Meds, LLC. recalls LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Hazard: Presence of Particulate matter. Recall due to presence of unknown particulate matter.
May 2, 2018DrugsFDA
Coastal Meds, LLC. recalls LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Hazard: Presence of Particulate matter. Recall due to presence of unknown particulate matter.
May 2, 2018DrugsFDA
Coastal Meds, LLC. recalls LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Hazard: Presence of Particulate matter. Recall due to presence of unknown particulate matter.
May 2, 2018DrugsFDA
Coastal Meds, LLC. recalls LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Hazard: Presence of Particulate matter. Recall due to presence of unknown particulate matter.
May 2, 2018DrugsFDA
Coastal Meds, LLC. recalls LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Hazard: Presence of Particulate matter. Recall due to presence of unknown particulate matter.
May 2, 2018DrugsFDA
Coastal Meds, LLC. recalls HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Hazard: Presence of Particulate matter. Recall due to presence of unknown particulate matter.
May 2, 2018DrugsFDA
Coastal Meds, LLC. recalls ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Hazard: Presence of Particulate matter. Recall due to presence of unknown particulate matter.