Drug Recall Terminated Historical recordClass II
Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply
- Reason
- Lack of Processing Controls.
- Recall initiated
- April 3, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- MS, LA, AR, IL, FL
FDA Drug Recalls
Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.
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Drug Recall Terminated Historical recordClass II
Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply
- Reason
- Lack of Processing Controls.
- Recall initiated
- April 3, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- MS, LA, AR, IL, FL
Drug Recall Terminated Historical recordClass II
Altera Handset NDC 83490-0678-05 56 days supply
- Reason
- Lack of Processing Controls.
- Recall initiated
- April 3, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- MS, LA, AR, IL, FL
Drug Recall Terminated Historical recordClass II
Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply
- Reason
- Lack of Processing Controls.
- Recall initiated
- April 3, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- MS, LA, AR, IL, FL
Drug Recall Terminated Historical recordClass II
Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply
- Reason
- Lack of Processing Controls.
- Recall initiated
- April 3, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- MS, LA, AR, IL, FL
Drug Recall Terminated Historical recordClass II
Otezla 30 mg tablet NDC 59572-0631-06 30 days supply;
- Reason
- Lack of Processing Controls.
- Recall initiated
- April 3, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- MS, LA, AR, IL, FL
Drug Recall Terminated Historical recordClass II
Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04
- Reason
- Lack of Processing Controls.
- Recall initiated
- April 3, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- MS, LA, AR, IL, FL
Drug Recall Terminated Historical recordClass II
Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57
- Reason
- Lack of Processing Controls.
- Recall initiated
- April 3, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- MS, LA, AR, IL, FL
Drug Recall Terminated Historical recordClass II
Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98
- Reason
- Lack of Processing Controls.
- Recall initiated
- April 3, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- MS, LA, AR, IL, FL
Drug Recall Terminated Historical recordClass II
Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01
- Reason
- Lack of Processing Controls.
- Recall initiated
- April 3, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- MS, LA, AR, IL, FL
Drug Recall Terminated Historical recordClass II
Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30
- Reason
- Lack of Processing Controls.
- Recall initiated
- April 3, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- MS, LA, AR, IL, FL
Drug Recall Terminated Historical recordClass II
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 day supply, Rx Only,
- Reason
- Lack of Processing Controls.
- Recall initiated
- April 3, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- MS, LA, AR, IL, FL
Drug Recall Terminated Historical recordClass II
Papaverine 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
- Reason
- 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.
- Recall initiated
- April 24, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- The recalled product was distributed to patients throughout the United States.
Drug Recall Terminated Historical recordClass II
Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.
- Reason
- 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.
- Recall initiated
- April 24, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- The recalled product was distributed to patients throughout the United States.
Drug Recall Terminated Historical recordClass II
Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc
- Reason
- 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.
- Recall initiated
- April 24, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- The recalled product was distributed to patients throughout the United States.
Drug Recall Terminated Historical recordClass II
Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
- Reason
- 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.
- Recall initiated
- April 24, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- The recalled product was distributed to patients throughout the United States.
Drug Recall Terminated Historical recordClass II
Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
- Reason
- 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.
- Recall initiated
- April 24, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- The recalled product was distributed to patients throughout the United States.
Drug Recall Terminated Historical recordClass II
Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
- Reason
- 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.
- Recall initiated
- April 24, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- The recalled product was distributed to patients throughout the United States.
Drug Recall Terminated Historical recordClass II
Metoprolol 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
- Reason
- 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.
- Recall initiated
- April 23, 2018
- Reported by FDA
- May 16, 2018
- Distribution
- Nationwide
Drug Recall Terminated Historical recordClass II
Docetaxel 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
- Reason
- Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
- Recall initiated
- April 27, 2018
- Reported by FDA
- May 9, 2018
- Distribution
- US nationwide
Data last updated:
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.
