Why it was recalled
Subpotent Drug
Product description
NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
Lot numbers, UPCs & expiration codes
Lot #s: 193040035S, Exp. 12/29/2019; 193120031S, Exp. 01/08/2020; 193150024S, Exp. 01/09/20; 193180030S, Exp. 01/12/20; 193240028S, Exp. 01/18/20; 193250022S, Exp. 01/19/20.
Where it was sold
Nationwide in the U.S.
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-0626-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 16, 2019
- FDA report date
- Jan 1, 2020
- Quantity
- 864 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-0626-2020, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 84525
- Address
- 150 N Field Dr Ste 350
- Code information
- Lot #s: 193040035S, Exp. 12/29/2019; 193120031S, Exp. 01/08/2020; 193150024S, Exp. 01/09/20; 193180030S, Exp. 01/12/20; 193240028S, Exp. 01/18/20; 193250022S, Exp. 01/19/20.
- Postal code
- 60045-2506
- Report date
- Jan 1, 2020
- Product type
- Drugs
- Recall number
- D-0626-2020
- Classification
- Class III
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 864 bags
- Termination date
- Feb 9, 2021
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Dec 16, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 23, 2019