Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags
Pharmedium Services, LLC is recalling specific lots of repinephrine bitartrate injection bags due to subpotency and discoloration confirmed by FDA analysis.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Pharmedium Services, LLC is recalling specific lots of NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black. The recall involves NDC 61553-127-61 and specific service codes and expiration dates listed in the source data.
The recall was initiated because FDA analysis confirmed the product was subpotent, following customer complaints regarding discoloration. The agency has classified this as a Class III recall, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Healthcare providers and patients should discontinue use of the affected lots and contact Pharmedium Services, LLC for further instructions or returns.
The recalled product
- Product
- 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
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injection
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Service Code 2K6127
- 15342123S
- exp 2/10/2016 15349071S
- exp 2/17/2016 and 15351050S
- exp 2/19/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Pharmedium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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