Reported Dec 19, 2018 · Terminated
Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma…
QuVa Pharma, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: QuVa Pharma, Inc. · 1075 W Park One Dr Ste 100 · Sugar Land, TX · 77478-2576
Is this the product you have?
- Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only
- Compounded byQuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05
- Lot codes and dates
- Lot #:10016014 Exp. 01/06/2019
- Amount recalled
- 168 bags
Where it was sold
Why it was recalled
Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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