Recalls / Class I
Class ID-0003-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lot #:30000271, Exp 10/1/18
Why it was recalled
Subpotent Drug: Product may not have the active ingredient present in the bag.
Recalling firm
- Firm
- QuVa Pharma, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1075 W Park One Dr Ste 100, N/A, Sugar Land, Texas 77478-2576
Distribution
- Quantity
- 528 bags
- Distribution pattern
- Nationwide to hospitals in USA
Timeline
- Recall initiated
- 2018-08-27
- FDA classified
- 2018-10-01
- Posted by FDA
- 2018-09-26
- Terminated
- 2019-04-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0003-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.