FDA Confirms Adrenaclick® Generic and EpiPen® Still in Short Supply with Advisories Warning Consumers to Check Devices for Defects

Perplexed Pharmacist

The Food and Drug Administration (FDA) publishes a database of drugs experiencing shortages which currently lists both the Adrenaclick Generic marketed by Amneal and EpiPen/EpiPen Generics marketed by Mylan.

Both brands are manufactured by Meridian Medical Technologies, a subsidiary of Pfizer. Meridian was warned by the FDA over their manufacturing practices and is currently the subject of an investigation by the US Attorney’s Office for the District of New York.

To add insult to injury, if you can find these brands at your local pharmacy, you still need to check the devices for manufacturing defects that could affect the delivery and purity of the drug.

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On July 10, the FDA reverified the shortage of EpiPen brand epinephrine auto-injectors currently plaguing the food allergy community:

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.3 mg (EpiPen® NDC 49502-500-02) (Authorized Generic NDC 49502-102-02) Available Meridian Medical Technologies, a subsidiary of Pfizer that manufactures EpiPen® and the authorized generic version, continues to experience manufacturing constraints. Currently, supplies will vary from pharmacy to pharmacy. Mylan, the distributor, is expediting shipments to wholesalers upon receipt from Pfizer. Patients who are experiencing difficulty accessing product should continue to contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies.

Dear Healthcare Provider Letter for Extended Expiration Dates for All Lots of EpiPen 0.3 mg Auto-Injectors and its Authorized Generic

Dear Healthcare Provider Letter for Potential Label Defect of EpiPen Auto-Injectors and its Authorized Generic

Manufacturing delays
0.15 mg (EpiPen® NDC 49502-501-02) (Authorized Generic NDC 49502-101-02) Available Meridian Medical Technologies, a subsidiary of Pfizer that manufactures EpiPen® and the authorized generic version, continues to experience manufacturing constraints. Currently, supplies will vary from pharmacy to pharmacy. Mylan, the distributor, is expediting shipments to wholesalers upon receipt from Pfizer. Patients who are experiencing difficulty accessing product should continue to contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies.

Dear Healthcare Provider Letter for Potential Label Defect of EpiPen Auto-Injectors and its Authorized Generic

Manufacturing delays

The “Dear Healthcare” links above access letters that authorize the extension of expiration dates for specific lots of the 0.3mg EpiPen and also provide a warning that certain lots may stick in their carrier tubes due to faulty labels.

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Late last month, the FDA reverified that the Impax Adrenaclick Generic, now marketed by Amneal Pharmaceuticals and sold by CVS and other outlets, remains in short supply:

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.15 mg/0.15 mL epinephrine injection, USP, pre-filled auto-injector (two pack)(NDC 0115-1695-49) On allocation

Dear Healthcare Provider Letter

Patient Inspection Instructions

Dear Healthcare Provider Letter for Expiry Extension for Select Lots of Epinephrine 0.15 mg and 0.30 mg Auto-Injectors

Manufacturing delays
0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector (two pack)(NDC 0115-1694-49) On allocation

Dear Healthcare Provider Letter

Patient Inspection Instructions

Dear Healthcare Provider Letter for Expiry Extension for Select Lots of Epinephrine 0.15 mg and 0.30 mg Auto-Injectors

Manufacturing delays

In this case, the “Dear Healthcare” links above access letters that authorize the extension of expiration dates for specific lots of both the 0.15mg and 0.3mg Adrenaclick Generics but also warn consumers to check specific lots:

This is to remind you to look at the epinephrine solution through the viewing window of the
auto-injector before use. If the solution is discolored (pinkish or brown color), cloudy, or
contains particles, do not use the auto-injector and return it to your pharmacy for replacement. Please contact Impax Generics at 1-800-934-6729 if you have questions about this information.

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On July 10, Amneal published a letter to shareholders warning them that continuing manufacturing difficulties were affecting the bottom line:

The Company also announced that as a result of continuing market pressure and additional competition on its key generic products, the uncertainty of supply of epinephrine auto-injector (generic Adrenaclick®) from its third-party supplier during the high seasonal third quarter, as well as delays in key product approvals and launches including generic NuvaRing®, it currently expects adjusted EBITDA for 2019 to now be in the range of $425 million to $475 million.

With no end in sight to the shortages of these products, consumers should consider other brands of emergency epinephrine devices if their device of preference is unavailable. The following brands are report no shortages:

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FDA Warns Pfizer’s Meridian over Handling of EpiPen Malfunctions
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