Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIKitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIProlia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIBotox 100 Units Vial NDC 00023-1145-01 90 days supply.
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIEnbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply;
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIRepatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IICayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIAltera Handset NDC 83490-0678-05 56 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IICosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IITaltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIOtezla 30 mg tablet NDC 59572-0631-06 30 days supply;
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIPulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIPolyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIPediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIKalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIAlbuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIHumira 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 day supply, Rx Only,
Lack of Processing Controls.
- 2018-05-16FDA-DrugVitalab Pharmacy, IncClass IIPapaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables, Vitalab Pharmacy, Inc
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.
- 2018-05-16FDA-DrugVitalab Pharmacy, IncClass IIPapaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.
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.
- 2018-05-16FDA-DrugVitalab Pharmacy, IncClass IIMethionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc
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.
- 2018-05-16FDA-DrugVitalab Pharmacy, IncClass IIPapaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
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.
- 2018-05-16FDA-DrugVitalab Pharmacy, IncClass IIAlprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
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.
- 2018-05-16FDA-DrugVitalab Pharmacy, IncClass IIMethylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
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.
- 2018-05-16FDA-DrugDr. Reddy's Laboratories, Inc.Class IIMetoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01
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.
- 2018-05-09FDA-DrugSanofi-Aventis U.S. LLCClass IIDocetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
- 2018-05-09FDA-DrugRhodes Pharmaceuticals, L.P.Class IIIAptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45
Failed Dissolution Specification: Low dissolution outside of specifications
- 2018-05-09FDA-DrugAuroMedics Pharma LLCClass IILevofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-52
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
- 2018-05-09FDA-DrugAuroMedics Pharma LLCClass IILevofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-244-47
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
- 2018-05-09FDA-DrugAuroMedics Pharma LLCClass IILevetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47.
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
- 2018-05-09FDA-DrugAuroMedics Pharma LLCClass IILevetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47.
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
- 2018-05-09FDA-DrugAuroMedics Pharma LLCClass IILevetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47.
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
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