Recalls / Class III
Class IIID-0295-2019
Product
Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05
- Affected lot / code info
- Lot #:10016014 Exp. 01/06/2019
Why it was recalled
Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Recalling firm
- Firm
- QuVa Pharma, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 1075 W Park One Dr Ste 100, N/A, Sugar Land, Texas 77478-2576
Distribution
- Quantity
- 168 bags
- Distribution pattern
- CA only
Timeline
- Recall initiated
- 2018-11-21
- FDA classified
- 2018-12-12
- Posted by FDA
- 2018-12-19
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0295-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.