Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
EpiPen Jr. 2-Pak (Epinephrine)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS: Epipen Auto-Injector Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.
Affected NDC
49502-0500-02
Compare with the code on your package — it is the most precise check available.
Drug: Epinephrine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Epipen epinephrine NDC 49502-0500 |
.3 mg/.3mL | Injection Intramuscular |
Viatris Specialty LLC | Rx |
- Recalling firm
- Meridian Medical Technologies a Pfizer Company
- NDC code
- 49502-500-02
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0691-2017 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Epinephrine recalls
See all
Class III · Low risk
Epinephrine Injection
Failed Impurities/Degradations Specifications
Class II · Moderate risk
EPINEPHRINE Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Maximum
Stability Data Does Not Support Expiry Date.
Class II · Moderate risk
Lidocaine HCI 2% and Epinephrine 1:100
Defective container: cracked/broken cartridges
Other recalls by Meridian Medical Technologies a Pfizer Company
All 2017 recalls
Class I · High risk
EpiPen 2-Pak
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Class II · Moderate risk
Diazepam Injection
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
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