D-0003-2019 Class I Terminated
FDA drug recall D-0003-2019 was initiated by QuVa Pharma, Inc. on Aug 27, 2018 and is designated Class I. Reason for recall: Subpotent Drug: Product may not have the active ingredient present in the bag. The recall status is terminated (terminated Apr 2, 2019). Affected quantity: 528 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 26, 2018
- Initiation Date
- Aug 27, 2018
- Termination Date
- Apr 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 528 bags
Product Description
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.
Distribution Pattern
Nationwide to hospitals in USA
Code Information
Lot #:30000271, Exp 10/1/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0003-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026