EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty ...

FDA Drug Recall #D-0691-2017 — Class I — March 12, 2017

Recall Summary

Recall Number D-0691-2017
Classification Class I — Serious risk
Date Initiated March 12, 2017
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Meridian Medical Technologies a Pfizer Company
Location Brentwood, MO
Product Type Drugs
Quantity 92,544 2-pak (U.S.); 198,579 syringes (O.U.S.)

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.

Reason for Recall

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

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.

Lot / 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 ***

Other Recalls from Meridian Medical Technologies a Pfize...

Recall # Classification Product Date
D-0690-2017 Class I EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 m... Mar 12, 2017
D-1369-2012 Class II Diazepam Injection, USP, 10 mg Automatic, Autoi... Jun 6, 2012

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.