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Class III: unlikely to cause harmTerminated

QuVa Pharma Norepinephrine 8 mg Recall

Norepinephrine 8 mg (32 mcg/mL) added to 0

QuVa Pharma, Inc. · Sugar Land, TX

Risk level
Class III
Reported by FDA
Dec 19, 2018
Recall ID
D-0295-2019
Check your lot numberHow we source this data

Summary

QuVa Pharma recalled Norepinephrine 8 mg starting Nov 21, 2018. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0295-2019 on Dec 19, 2018. Reason: Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride. Status: Terminated.

Why it was recalled

Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

Product description

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

Lot numbers, UPCs & expiration codes

Lot #:10016014 Exp. 01/06/2019

Where it was sold

CA only

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0295-2019
Classification
Class III
Status
Terminated
Recall initiated
Nov 21, 2018
FDA report date
Dec 19, 2018
Quantity
168 bags
Recall type
Voluntary: Firm initiated
Recalling firm
QuVa Pharma, Inc.

Original FDA data

Every field from FDA enforcement report D-0295-2019, exactly as published.

Show all FDA fields
City
Sugar Land
State
TX
Status
Terminated
Country
United States
Event ID
81644
Address
1075 W Park One Dr Ste 100
Code information
Lot #:10016014 Exp. 01/06/2019
Postal code
77478-2576
Report date
Dec 19, 2018
Product type
Drugs
Recall number
D-0295-2019
Classification
Class III
Recalling firm
QuVa Pharma, Inc.
Product quantity
168 bags
Termination date
May 1, 2019
Reason for recall
Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
CA only
Recall initiation date
Nov 21, 2018
Initial firm notification
Telephone
Center classification date
Dec 12, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0295-2019, published Dec 19, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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