Why it was recalled
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Product description
NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61
Lot numbers, UPCs & expiration codes
Service Code 2K6134; 15342084S, 15342191S, 15342223S, 15342224S, 15342225S, and 15342226S, exp 2/10/2016; 15343025S, 15343026S, 15343129S, and 15343131S, exp 2/11/2016; 15344157S, 15344160S, and 15344209S, exp 2/12/2016; 15345036S, 15345104S, 15345106S, and 15345142S, exp 2/13/2016; 15346015S, 15346016S, 15346017S, 15346018S, 15346019S, 15346020S, 15346022S, and 15346023S, exp 2/14/2016; 15348152S, and 15348197S, exp 2/16/2016 15350046S, and 15350154S, exp 2/18/2016
Where it was sold
Nationwide
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-0777-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 31, 2015
- FDA report date
- Mar 23, 2016
- Quantity
- 6,816 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-0777-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 72973
- Address
- 150 N Field Dr Ste 350
- Code information
- Service Code 2K6134; 15342084S, 15342191S, 15342223S, 15342224S, 15342225S, and 15342226S, exp 2/10/2016; 15343025S, 15343026S, 15343129S, and 15343131S, exp 2/11/2016; 15344157S, 15344160S, and 15344209S, exp 2/12/2016; 15345036S, 15345104S, 15345106S, and 15345142S, exp 2/13/2016; 15346015S, 15346016S, 15346017S, 15346018S, 15346019S, 15346020S, 15346022S, and 15346023S, exp 2/14/2016; 15348152S, and 15348197S, exp 2/16/2016 15350046S, and 15350154S, exp 2/18/2016
- Postal code
- 60045-2506
- Report date
- Mar 23, 2016
- Product type
- Drugs
- Recall number
- D-0777-2016
- Classification
- Class III
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 6,816 bags
- Termination date
- Apr 6, 2016
- Reason for recall
- Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 31, 2015
- Initial firm notification
- Center classification date
- Mar 17, 2016