D-0730-2018 Class II Terminated
FDA drug recall D-0730-2018 was initiated by Vitalab Pharmacy, Inc on April 24, 2018 and is designated Class II. Reason for recall: 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 producti… The recall status is terminated (terminated January 23, 2020). Affected quantity: 22 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 16, 2018
- Initiation Date
- April 24, 2018
- Termination Date
- January 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 vials
Product Description
Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
Reason for Recall
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.
Distribution Pattern
The recalled product was distributed to patients throughout the United States.
Code Information
Lot #: 03092018@52, 02122018@76, Exp 05/13/2018-06/07/2018