Pharmedium Recalls Subpotent Epinephrine Injection Bags
Pharmedium Services, LLC is recalling 6,816 bags of subpotent epinephrine injection due to discoloration and FDA-confirmed potency issues.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard involves subpotent medication and discoloration, which fits the criteria for moderate severity due to the potential for therapeutic failure without immediate severe injury.
Plain-English summary
Pharmedium Services, LLC is recalling 6,816 bags of NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP. The product is distributed in 250 mL Viaflex bags and is prescription-only. The recall is nationwide.
The recall was initiated following customer complaints regarding discoloration of the product. Subsequent analysis by the FDA confirmed that the drug was subpotent, meaning it did not contain the full amount of the active ingredient required. The agency has classified this recall as Class III.
The affected product includes specific lot codes with expiration dates ranging from February 10, 2016, to February 18, 2016. Healthcare providers and patients should check their inventory for the specific NDC 61553-134-61 and the listed lot codes. If the product is found, it should be quarantined and not administered.
The recalled product
- Product
- 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
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injection
- Affected units
- 6,816
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 (20)
- 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
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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