FDA Recall D-0003-2019
QuVa Pharma, Inc. · Sugar Land, TX
Class I — life-threatening Terminated 218 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.
Reason for recall
Subpotent Drug: Product may not have the active ingredient present in the bag.
Recall record
- Recall number
D-0003-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide to hospitals in USA
- Recall initiated
- 2018-08-27
- Classified by FDA Center
- 2018-10-01
- FDA published
- 2018-09-26
- Terminated
- 2019-04-02
- Recalling firm
- QuVa Pharma, Inc.
- Firm location
- Sugar Land, TX