Adrenalin Chloride Epinephrine Nasal Solution Recalled for Misleading Label
Par Pharmaceutical is recalling Adrenalin Chloride Solution (Epinephrine Nasal Solution) due to a misleading label that resembles the FDA-approved Adrenalin epinephrine injection product, creating potential confusion.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires minimum severity of 4. Although no illnesses or injuries have been reported, the misleading labeling of an epinephrine product creates a real risk of medication confusion with serious health consequences possible.
Plain-English summary
ENDO USA, Inc., distributed by Par Pharmaceutical, is recalling Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP) 30mg/30mL (1mg/mL) packaged in 30 mL amber glass vials. The recall affects 44,397 vials and includes all lots currently within expiry.
The product's label is misleading and similar in appearance to the FDA-approved Adrenalin (epinephrine injection, USP) product. This labeling issue creates a risk of product confusion between the nasal solution formulation and the injection formulation.
The product was distributed nationwide throughout the United States. This is a Class I recall issued by the FDA.
The recalled product
- Product
- Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01
- Manufacturer
- ENDO USA, Inc.
- Category
- Drug
- Hazard
- Affected units
- 44,397
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 (1)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
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