EpiPen Auto-Injectors Recalled for Defective Delivery System
Meridian Medical Technologies is recalling EpiPen auto-injectors because the delivery system may fail to activate, preventing patients from receiving epinephrine.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which is defined as a situation where use of or exposure to a product may reasonably be expected to cause serious adverse health consequences or the death.
Plain-English summary
Meridian Medical Technologies, a Pfizer company, is recalling EpiPen (epinephrine) 2-Pak Auto-Injectors 0.3 mg. The recall involves specific lots distributed nationwide in the United States, in Puerto Rico, and in multiple international markets. The affected products are prescription-only medications used to treat severe allergic reactions.
The recall is being issued because of 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 patients who rely on the auto-injector for emergency treatment.
Consumers and healthcare providers should check the lot numbers and expiration dates on their EpiPen packages against the list provided in the official recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a replacement or refund. Patients should consult their healthcare provider for alternative emergency treatment options if their device is affected.
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 (20)
- US: lot 5GM631
- exp. April 2017
- lot 5GM640
- exp. May 2017
- lot 6GM072
- exp. Sep 2017
- lot 6GM082
- lot 6GM088
- exp. Oct 2017
- lot 6GM087
- lot 6GM198
- lot 6GM081
- lot 6GM091
- lot 6GM199
- exp. Oct 2017: INTERNATIONAL: lot 5FA665
- lot 5GU763
- lot 6FA293
- lot 6FA292
- lot 6GH294
- exp. Oct 2017.
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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