PharMEDium Recalls NOrepinephrine Injection Due to Subpotency
PharMEDium Services recalls specific lots of NOrepinephrine Bitartrate injection due to subpotent drug issues confirmed by FDA analysis.
Use caution until it’s fixed
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
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What happened, in plain English
PharMEDium Services, LLC is recalling NOrepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP in Viaflex bags. The recall was initiated because FDA analysis confirmed the drug is subpotent, following customer complaints of discoloration. This affects 6,816 bags distributed nationwide with expiration dates ranging from February 10, 2016, to February 18, 2016. Read more at govinfonow.com/recall/43299-pharmedium-recalls-norepinephrine-injection-due-to-subpotency.
Source Summary by GovInfoNow · govinfonow.com/recall/43299-pharmedium-recalls-norepinephrine-injection-due-to-subpotency · Updated October 11, 2026 · FDA enforcement record: FDA #D-0777-2016
Cite this page
“PharMEDium Recalls NOrepinephrine Injection Due to Subpotency.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43299-pharmedium-recalls-norepinephrine-injection-due-to-subpotency. Based on FDA recall #D-0777-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0777-2016%22&limit=1).
Why it’s dangerous
The recalled bags contain a subpotent amount of the active ingredient, meaning they may not deliver the full dose required to treat the condition effectively. While the record notes customer complaints of discoloration, the primary confirmed hazard is the reduced potency of the drug itself.
Who’s affected
Healthcare providers and patients who received or are using the specific lots of NOrepinephrine Bitartrate injection distributed nationwide. Patients relying on this medication for treatment may be at risk if the subpotent drug does not provide the expected therapeutic effect.
How to tell if you have this one
Check if you have NOrepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP in a 250 mL Viaflex Bag manufactured by PharMEDium Services, LLC. Look for NDC 61553-134-61 and Service Code 2K6134. Affected lots include those starting with 15342, 15343, 15344, 15345, 15346, 15348, and 15350, with expiration dates between 2/10/2016 and 2/18/2016.
- Brand
PharMEDium Services- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0777-2016 | 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; 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 | 6,816 bags |
| D-0778-2016 | NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61; Service Code 2K6127; 15342123S, exp 2/10/2016 15349071S, exp 2/17/2016 and 15351050S, exp 2/19/2016 | — |
What to do — step by step
Identify Affected Lots
Verify if your product matches the NDC 61553-134-61, Service Code 2K6134, and specific lot numbers listed in the recall record.
Contact Healthcare Provider
Consult with your doctor or pharmacist immediately to discuss alternative treatments if you are using one of the recalled lots.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What are the specific lot numbers and expiration dates affected?
Affected lots include 15342084S (exp 2/10/2016), 15343025S (exp 2/11/2016), 15344157S (exp 2/12/2016), 15345036S (exp 2/13/2016), 15346015S (exp 2/14/2016), 15348152S (exp 2/16/2016), and 15350046S (exp 2/18/2016), among others listed in the record.
How many bags are included in this recall?
The recall covers 6,816 bags of the specified injection product.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0777-2016 (December 31, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0777-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.