EpiPen Jr. Auto-Injectors Recalled for Delivery System Defects
Meridian Medical Technologies is recalling EpiPen Jr. auto-injectors because the delivery system may fail to activate, preventing patients from receiving epinephrine.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. The rubric mandates a score of 5 for FDA Class I recalls.
Plain-English summary
Meridian Medical Technologies, a Pfizer company, is recalling EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg. The recall involves specific lots of the product distributed in the United States, Puerto Rico, and various international markets. The affected units are prescription-only medications manufactured for Mylan Specialty L.P.
The recall was initiated due to a defective delivery system. Reports indicate that the device may fail to activate, which could result in a patient not receiving the necessary medication. This failure poses a risk to individuals who rely on the auto-injector for emergency treatment of severe allergic reactions.
Consumers and healthcare providers should check the lot numbers and expiration dates on their EpiPen Jr. packages against the recall list. If the product matches the recalled lots, it should not be used. Patients should contact their healthcare provider or pharmacist for guidance on obtaining a replacement device.
The recalled product
- Product
- EPIPEN (EPINEPHRINE)
- Brand
- EPIPEN
- Manufacturer
- Meridian Medical Technologies a Pfizer Company
- Category
- Drug — Auto-Injector
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 (10)
- US lot 5GN767
- expiration April 2017
- lot 5GN773
- lot 6GN215
- expiration Sep 2017: INTERNATIONAL lot 5GR765
- expiration March 2017
- lot 5GK771
- lot 5ED824
- and lot 6ED117
- expiration ***
Distribution
Part of a larger recall action
This product is one of 2 recalled by Meridian Medical Technologies a Pfizer Company 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.
See all 2 products in this recall →Related recalls
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