Why it was recalled
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Product description
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.
Lot numbers, UPCs & expiration codes
US lot 5GN767, expiration April 2017; lot 5GN773, expiration April 2017; lot 6GN215, expiration Sep 2017: INTERNATIONAL lot 5GR765, expiration March 2017; lot 5GK771, expiration April 2017; lot 5ED824, expiration April 2017; and lot 6ED117, expiration ***
Where it was sold
Nationwide and Puerto Rico, Argentina, Austria, Australia, Belgium, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Japan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Sweden, Switzerland, Taiwan, Thailand, United Kingdom. There has been no U.S. government or military distribution.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0691-2017
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Mar 12, 2017
- FDA report date
- May 10, 2017
- Quantity
- 92,544 2-pak (U.S.); 198,579 syringes (O.U.S.)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Meridian Medical Technologies a Pfizer Company
Original FDA data
Every field from FDA enforcement report D-0691-2017, exactly as published.
Show all FDA fields
- City
- Brentwood
- State
- MO
- Status
- Ongoing
- Country
- United States
- Event ID
- 76789
- Address
- 2555 Hermelin Dr
- Code information
- US lot 5GN767, expiration April 2017; lot 5GN773, expiration April 2017; lot 6GN215, expiration Sep 2017: INTERNATIONAL lot 5GR765, expiration March 2017; lot 5GK771, expiration April 2017; lot 5ED824, expiration April 2017; and lot 6ED117, expiration ***
- Postal code
- 63144-2504
- Report date
- May 10, 2017
- Product type
- Drugs
- Recall number
- D-0691-2017
- Classification
- Class I
- Recalling firm
- Meridian Medical Technologies a Pfizer Company
- Product quantity
- 92,544 2-pak (U.S.); 198,579 syringes (O.U.S.)
- Reason for recall
- Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide and Puerto Rico, Argentina, Austria, Australia, Belgium, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Japan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Sweden, Switzerland, Taiwan, Thailand, United Kingdom. There has been no U.S. government or military distribution.
- Recall initiation date
- Mar 12, 2017
- Initial firm notification
- Press Release
- Center classification date
- Apr 28, 2017