EpiPen JR Auto-Injector FDA Alerts

Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API) Due to Discoloration of Product

January 9, 2023 -- Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical ingredient (API) used to manufacture or compound prescription products, to the user level. Customer complaints have found the product to be discolored.

Risk Statement: Epinephrine is a critical medication used during life-threatening conditions which can affect any age and any person. The use of a finished dose product manufactured or compounded with this recalled product could result in less-effective product, and incomplete treatment of life-threatening conditions including, low blood pressure, heart failure, anaphylaxis, irregular heartbeat, and heart attack. Treatment with a less-effective product, essentially underdosing epinephrine, could result in death. Spectrum Laboratory Products, Inc. has not received any reports of adverse events related to this recall.

Epinephrine (L-Adrenaline) USP bulk API Powder, is used in manufacturing and compounding of finished dose epinephrine prescription products which can be used to treat a variety of medical conditions including anaphylaxis and other severe immediate hypersensitivity reactions, asthma, bronchospasm, airway edema, nasal congestion, dilation during intraocular surgery, vasoconstrictor with local anesthetics, hypotension or shock, heart failure, bradycardia or atrioventricular block, and sudden cardiac arrest. The Epinephrine (L-Adrenaline) USP bulk API Powder is packaged in amber glass bottles enclosed in a vacuum sealed pouch. NDC’s, Package sizes, lot numbers and expiration dates can be found in the table below. The affected Epinephrine, USP product can be identified by Spectrum catalog number EP130. Product was distributed directly from Spectrum facilities nationwide in the USA and to Canada.

Spectrum Laboratory Products, Inc. is notifying its distributors and customers by certified mail, email and phone, and arranging for return of all recalled products. Consumers, distributors, or retail pharmacies that have Epinephrine, USP catalog number EP130, which is being recalled, should stop use immediately and return to place of purchase.

Consumers with questions regarding this recall can contact Spectrum Laboratory Products, Inc. by 800-772-8786 or compliance@spectrumchemical.com on Monday to Friday from 8 am to 5 pm, pacific time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

FDA Alerts Patients and Health Care Professionals of Amneal and Impax Laboratories Epinephrine Auto-Injector Device Malfunctions

June 1, 2020 -- FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present.

In letters to health care professionals and consumers, Impax Laboratories LLC, a subsidiary of Amneal Pharmaceuticals LLC, the manufacturer of the epinephrine auto-injector, detailed how certain lots of these devices might not contain the yellow “stop collar” component. If the auto-injector is missing the yellow “stop collar” component, the device has the potential safety risk of delivering a double dose of epinephrine to a patient. It is vital for lifesaving products to work as designed in an emergency situation.

Patients, pharmacists and health care professionals who have received Amneal or Impax’s epinephrine auto-injector after December 20, 2018, should immediately visually inspect the auto-injector to confirm the presence of the yellow “stop collar” by:

1. Removing the auto-injector from the carrying case.
2. Placing the auto-injector on a flat surface.
3. Locating the edge of the label that states, “Peel here for further instructions.” Lift the label edge until you see the clear part of the auto-injector.
4. Looking for the yellow “stop collar” inside the clear part of the auto-injector. If the yellow “stop collar” is not visible inside the clear part of the auto-injector, gently rotate the blue sheath remover, without pulling or removing the blue sheath remover, to observe if the yellow “stop collar” comes into view inside the clear part of the auto-injector.
5. If yellow “stop collar” is present, then the product is safe to use, and no further action is necessary. Re-wrap the label to its original position and place the auto-injector into the carrying case.

Patients and health care professionals should contact the Amneal Drug Safety Department at 1(877) 835-5472 to assist in determining if the yellow “stop collar” is missing and to make arrangements to return defective devices and obtain a replacement at no additional cost. Patients should contact their pharmacy regarding a replacement epinephrine auto-injector before returning the defective device to Amneal.

FDA recommends that patients inspect their auto-injector devices as soon as possible and immediately contact the Amneal Drug Safety Department if they have questions about inspecting their auto-injector device, or if they’re unsure if the yellow “stop collar” is missing.

Pharmacists should inspect the products before dispensing them to patients to ensure the yellow “stop collar” is present. If the yellow “stop collar” is missing, pharmacists should not dispense the product and should contact Amneal.

The yellow “stop collar” is one of several components that work together to assure proper dosing of the auto-injector. While some patients require a second dose of epinephrine, an epinephrine overdose has the potential to cause severe patient harm or death. As stated on the product label, consumers should always seek emergency medical help right away after using their epinephrine auto-injector.

FDA reminds patients and health care professionals that epinephrine auto-injectors are available through additional manufacturers.

FDA is notifying patients and caregivers that epinephrine auto-injectors are not being recalled. We urge patients and caregivers to use the epinephrine auto-injector they have on hand and be aware of the potential issues outlined in the statement above.

FDA is continuously monitoring adverse events reported with epinephrine auto-injector products. FDA asks health care professionals and consumers to report any adverse events or quality problems to the FDA’s MedWatch program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Source: FDA

FDA Alerts Patients and Health Care Professionals of EpiPen Auto-Injector Errors Related to Device Malfunctions and User Administration

March 24, 2020 -- FDA is alerting patients, caregivers and health care professionals that EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may potentially have delayed injection or be prevented from properly injecting due to:

1. Device failure from spontaneous activation caused by using sideways force to remove the blue safety release
2. Device failure from inadvertent or spontaneous activation due to a raised blue safety release
3. Difficulty removing the device from the carrier tube
4. User errors

In a letter to health care professionals from Pfizer, the manufacturer of the EpiPen, and Mylan, detailed how these devices may activate prematurely if the blue safety release is removed using a sideway force. For example, a user may try to hold a device with only one hand and try to remove the blue safety release with their thumb in a sideways force. Prior to use, the blue safety release should be removed by pulling straight up with one hand and holding the device with the other hand.

A very limited number of EpiPen devices also may have a blue safety release that is slightly raised. If the blue safety release is raised, the device may activate prematurely, which could potentially delay or prevent emergency treatment when needed.

Additionally, in some cases EpiPen devices may not slide out of their carrier tube easily, or potentially at all, due to a slight deformation on the rim of the carrier tube. The carrier tube is the immediate package in which the auto-injector is contained. In some cases, the patient or caregiver may not be able to quickly remove the auto-injector from the carrier tube.

The letter also describes specific user errors that can delay or prevent the administration of the intended dose of epinephrine. For example:

• The device will not activate if the blue safety release is in place
• Ensure the needle end (orange end of the device) is in contact with the outer thigh (upper leg) prior to and during activation. The EpiPen device should be administered by swinging and pushing firmly against the outer thigh until it “clicks.” This signals that injection has started.
• Ensure the device is held in place for a minimum of three seconds following activation.

It is important for health care providers, patients and caregivers to periodically review the EpiPen user instructions and practice using the EpiPen trainer to ensure proper understanding and utilization of the EpiPen auto-injector.

It is vital for lifesaving products to work as designed in an emergency situation, and patients and caregivers should inspect their epinephrine auto-injector prior to needing it to ensure the blue safety release is not raised and that the device can be easily removed from the carrier tube.

Patients should contact Mylan Customer Relations at 800-796-9526 if they find an issue with their auto-injector and to obtain a replacement at no additional cost. Pharmacists should inspect the products before dispensing them to patients to ensure quick access to the auto-injector and should not dispense any product which does not easily slide out of its carrier tube or has a raised blue safety release. As stated on the product label, consumers should always seek emergency medical help right away after using their epinephrine auto-injector.

FDA is aware of adverse event reports associated with EpiPen products. FDA asks health care professionals and consumers to report any adverse reactions or quality problems to the FDA’s MedWatch program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm.
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Source: FDA

FDA Alerts Patients and Health Care Professionals that Some EpiPen Auto-Injectors May Not Readily Slide Out of Carrier Tube

[11/2/2018] FDA is alerting patients, caregivers and health care professionals that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product.

In a letter to health care professionals from Pfizer, the manufacturer of the Mylan EpiPen, the label sticker on the auto-injector unit may have been improperly applied, causing resistance when removing it from the carrier tube. The carrier tube is the immediate package in which the auto-injector is contained. In some cases, the patient or caregiver may not be able to quickly remove the epinephrine auto-injector from the carrier tube.

The auto-injector device and the epinephrine it delivers are not affected by this issue and can be used as prescribed. It is vital for lifesaving products to work as designed in an emergency situation, and patients and caregivers should inspect their epinephrine auto-injector prior to needing it to ensure they can quickly access the product.

The letter also describes how to inspect potentially affected products and explains that patients should contact Mylan Customer Relations at 800-796-9526 if an auto-injector does not slide out easily from the carrier tube OR the label is not fully adhered to the auto-injector. Pharmacists should inspect the products before dispensing them to patients to ensure quick access to the auto-injector and should not dispense any product which does not easily slide out of its carrier tube.    

FDA is not aware of any adverse event reports associated with improperly applied EpiPen or EpiPen Jr auto-injectors, or their authorized generics label. As stated on the product label, consumers should always seek emergency medical help right away after using their epinephrine auto-injector.

EpiPen and and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device

ISSUE: Mylan N.V. announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets.

This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Both reports are related to the single lot that was previously recalled.

The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty between December 2015 and July 2016. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies. See the firms press release for a list of affected product lot numbers.

Update: Mylan Provides Update on Meridian Medical Technologies', a Pfizer Company, Expanded Voluntary Worldwide Recall of EpiPen® Auto-Injector - March 31, 2017

BACKGROUND: The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America.

RECOMMENDATION: Patients, customers and distributors are being notified and should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions. We are asking patients to keep their existing product until their replacement product can be secured.

Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability. The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector.

It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device. 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[03/31/2017 - News Release -  FDA]